Atlas FDA

PALINDROME PRECISION H CHRONIC CATHETER, PALINDROME PRECISION SI CHRONIC CATHETER, PALINDROME PRECISION HSI CHRONIC CATH

FDA 510(k) clearance K123196 · decided 2013-01-31

Clearance details

K-number
K123196
Device name
PALINDROME PRECISION H CHRONIC CATHETER, PALINDROME PRECISION SI CHRONIC CATHETER, PALINDROME PRECISION HSI CHRONIC CATH
Applicant
Covidien
Decision
Substantially Equivalent
Date received
2012-10-11
Decision date
2013-01-31
Days to decision
112 days
Clearance type
Traditional
Product code
MSD
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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Recalls involving this device

RecordFirmDate
Palindrome Precision Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane cathete recall (Z-1885-2025)Mozarc Medical US LLC2025-05-30
Palindrome Precision HSI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane cat recall (Z-1886-2025)Mozarc Medical US LLC2025-05-30
Palindrome Precision SI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane cath recall (Z-1887-2025)Mozarc Medical US LLC2025-05-30
Palindrome Precision H Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane cathe recall (Z-1888-2025)Mozarc Medical US LLC2025-05-30
MAHURKAR Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter. recall (Z-1889-2025)Mozarc Medical US LLC2025-05-30
Palindrome Precision HSI Chronic Catheter Sport Pack 14.5 Fr/Ch (4.8mm) x 19 cm (Symmetric recall (Z-1634-2024)Covidien LP2024-04-24
Palindrome Precision H Chronic Catheter Kit 14.5 Fr/Ch (4.8mm) x 23 cm (Symmetrical Tip, H recall (Z-1635-2024)Covidien LP2024-04-24
Palindrome Precision Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access f recall (Z-1312-2022)Covidien Llc2022-07-07
Palindrome Precision H Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access recall (Z-1313-2022)Covidien Llc2022-07-07
Palindrome Precision SI Chronic Catheter, Sterile, Single Use, Rx Only. For vascular acces recall (Z-1314-2022)Covidien Llc2022-07-07
Palindrome Precision HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chr recall (Z-1315-2022)Covidien Llc2022-07-07
Palindrome" Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) recall (Z-0329-2016)Covidien LLC2015-11-24
Palindrome Precision Chronic Catheter Kit Symmetrical Tip 14.5 Fr/Ch (4.8mm) X 33 cm Item recall (Z-0330-2016)Covidien LLC2015-11-24
Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch recall (Z-0331-2016)Covidien LLC2015-11-24
Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch recall (Z-0332-2016)Covidien LLC2015-11-24
Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Pre-Curved Shaft and Tal VenaTr recall (Z-0333-2016)Covidien LLC2015-11-24
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 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 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
Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: recall (Z-1899-2015)Covidien LLC2015-07-01
Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: recall (Z-1900-2015)Covidien LLC2015-07-01
Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: recall (Z-1901-2015)Covidien LLC2015-07-01
Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: recall (Z-1902-2015)Covidien LLC2015-07-01
Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: recall (Z-1903-2015)Covidien LLC2015-07-01
Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 19cm Item recall (Z-1908-2015)Covidien LLC2015-07-01
Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 23cm Item recall (Z-1909-2015)Covidien LLC2015-07-01
Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm Item recall (Z-1910-2015)Covidien LLC2015-07-01
Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 33cm Item recall (Z-1911-2015)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