Atlas FDA

PALINDROME H, SI, HSI CHRONIC CATHETER

FDA 510(k) clearance K112477 · decided 2011-09-28

Clearance details

K-number
K112477
Device name
PALINDROME H, SI, HSI CHRONIC CATHETER
Applicant
Covidien
Decision
Unknown
Date received
2011-08-29
Decision date
2011-09-28
Days to decision
30 days
Clearance type
Special
Product code
NYU
Device class
2
Regulation number
876.5540
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Mansfield, MA, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
PALINDROME EMERALD 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING (K060509)Tyco Healthcare Group2006-06-23

Recalls involving this device

RecordFirmDate
Palindrome H Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodia recall (Z-1317-2022)Covidien Llc2022-07-07
Palindrome SI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodi recall (Z-1318-2022)Covidien Llc2022-07-07
Palindrome HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemod recall (Z-1319-2022)Covidien Llc2022-07-07
Palindrome SI Chronic Catheter Kit 14.5 Fr x 19cm Item Code: 8888245062 The Palindrome SI recall (Z-1850-2015)Covidien LLC2015-07-01
Palindrome SI Chronic Catheter Kit 14.5 Fr x 23cm Item Code: 8888245063 recall (Z-1851-2015)Covidien LLC2015-07-01
Palindrome SI Chronic Catheter Kit 14.5 Fr x 28cm Item Code: 8888245064 recall (Z-1852-2015)Covidien LLC2015-07-01
Palindrome SI Chronic Catheter Kit 14.5 Fr x 28cm Item Code: 8888245064 recall (Z-1853-2015)Covidien LLC2015-07-01
Palindrome SI Chronic Catheter Kit 14.5 Fr x 28cm Item Code: 8888245064 recall (Z-1854-2015)Covidien LLC2015-07-01
Palindrome SI Chronic Catheter Sport Pack 14.5 Fr x 33 cm Item Code: 8888233508 recall (Z-1857-2015)Covidien LLC2015-07-01
Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145062 recall (Z-1858-2015)Covidien LLC2015-07-01
Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145062C recall (Z-1859-2015)Covidien LLC2015-07-01
Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145063 recall (Z-1860-2015)Covidien LLC2015-07-01
Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145063C recall (Z-1861-2015)Covidien LLC2015-07-01
Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code:8888145064 recall (Z-1862-2015)Covidien LLC2015-07-01
Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145064C recall (Z-1863-2015)Covidien LLC2015-07-01
Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145065 recall (Z-1864-2015)Covidien LLC2015-07-01
Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145065C recall (Z-1865-2015)Covidien LLC2015-07-01
Palindrome SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 8888145066 recall (Z-1866-2015)Covidien LLC2015-07-01
Palindrome SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 8888145066C recall (Z-1867-2015)Covidien LLC2015-07-01
Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8 recall (Z-1868-2015)Covidien LLC2015-07-01
Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8 recall (Z-1869-2015)Covidien LLC2015-07-01
Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8 recall (Z-1870-2015)Covidien LLC2015-07-01
Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8 recall (Z-1871-2015)Covidien LLC2015-07-01
Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8 recall (Z-1872-2015)Covidien LLC2015-07-01
Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8 recall (Z-1873-2015)Covidien LLC2015-07-01
Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8 recall (Z-1874-2015)Covidien LLC2015-07-01
Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cmItem Code: 88 recall (Z-1875-2015)Covidien LLC2015-07-01
Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 44cm Item Code: 8888146144P recall (Z-1876-2015)Covidien LLC2015-07-01
Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 44cm Item Code: 8888146144CP recall (Z-1877-2015)Covidien LLC2015-07-01
Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 8888145066P recall (Z-1878-2015)Covidien LLC2015-07-01
Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 8888145066CP recall (Z-1879-2015)Covidien LLC2015-07-01
Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 8888145066CP recall (Z-1880-2015)Covidien LLC2015-07-01
Palindrome SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888 recall (Z-1881-2015)Covidien LLC2015-07-01
Palindrome SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888 recall (Z-1882-2015)Covidien LLC2015-07-01
Palindrome SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888 recall (Z-1883-2015)Covidien LLC2015-07-01
Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 19cm Item recall (Z-1884-2015)Covidien LLC2015-07-01
Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 23cm Item recall (Z-1885-2015)Covidien LLC2015-07-01
Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm Item recall (Z-1886-2015)Covidien LLC2015-07-01
Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 33cm Item recall (Z-1887-2015)Covidien LLC2015-07-01
Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 33cm Item recall (Z-1888-2015)Covidien LLC2015-07-01
Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145057 recall (Z-1889-2015)Covidien LLC2015-07-01
Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145048 recall (Z-1890-2015)Covidien LLC2015-07-01
Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145048 recall (Z-1891-2015)Covidien LLC2015-07-01
Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145049 recall (Z-1892-2015)Covidien LLC2015-07-01
Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code:8888145049C recall (Z-1893-2015)Covidien LLC2015-07-01
Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145050 recall (Z-1894-2015)Covidien LLC2015-07-01
Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145050 recall (Z-1895-2015)Covidien LLC2015-07-01
Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145050 recall (Z-1896-2015)Covidien LLC2015-07-01
Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: recall (Z-1897-2015)Covidien LLC2015-07-01
Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: recall (Z-1898-2015)Covidien LLC2015-07-01

PMA approvals by this applicant

RecordFirmDate
MODEL 1010 ULTRAHIGH FREQUENCY VENTILATOR (P890034/S006)Covidien1997-06-24
MODEL 1010 ULTRAHIGH FREQUENCY VENTILATOR (P890034/S005)Covidien1995-12-28
MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR (P890034/S004)Covidien1995-06-14
MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR (P890034/S003)Covidien1994-06-17
MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR (P890034/S002)Covidien1994-03-28
MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR (P890034/S001)Covidien1993-09-10
MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR (P890034)Covidien1991-12-13