Atlas FDA

KEDALL 14.5 FR CHRONIC HEMODIALYSIS CATHETER W/SILVER IMPREGNATED SLEEVE (PALINDROME RUBY)

FDA 510(k) clearance K060972 · decided 2006-08-04

Clearance details

K-number
K060972
Device name
KEDALL 14.5 FR CHRONIC HEMODIALYSIS CATHETER W/SILVER IMPREGNATED SLEEVE (PALINDROME RUBY)
Applicant
Kendall
Decision
Substantially Equivalent
Date received
2006-04-07
Decision date
2006-08-04
Days to decision
119 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 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 SI Chronic Catheter Sport Pack 14.5 Fr x 23 cm Item Code: 8888223408 recall (Z1855-2015)Covidien LLC2015-07-01
Palindrome SI Chronic Catheter Sport Pack 14.5 Fr x 28 cm Item Code:8888228458 recall (Z1856-2015)Covidien LLC2015-07-01