Panels › Gastroenterology, Urology › Product code NYU · Class 2
Catheter, Hemodialysis, Implanted, Coated
Regulation 876.5540
0510(k)s in 12 months (2 all time)
0recalls in 12 months (30 all time)
30recalls that name a 510(k)
Top companies in NYU
| Company | 510(k)s | Recalls |
|---|---|---|
| Covidien | 1 | 30 |
| Tyco Healthcare Group | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 24, 2015 | Covidien LLC Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Pre-Curved Shaft and Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm
Item Number: 8888145061P
The Palindrome chronic catheter is intended fo Terminated |
NYU | K123196 |
| Nov 24, 2015 | Covidien LLC Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm
Item Number: 8888145046C
The Palindrome chronic catheter is intended for acute and chronic h Terminated |
NYU | K123196 |
| Nov 24, 2015 | Covidien LLC Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm
Item Number: 8888145042P
The Palindrome chronic catheter is intended for acute and chronic h Terminated |
NYU | K123196 |
| Nov 24, 2015 | Covidien LLC Palindrome Precision Chronic Catheter Kit Symmetrical Tip 14.5 Fr/Ch (4.8mm) X 33 cm
Item Number: 8888145017P
The Palindrome chronic catheter is intended for acute and chronic hemodialysis, apheresi Terminated |
NYU | K123196 |
| Nov 24, 2015 | Covidien LLC Palindrome" Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm
Item Number: 8888145042
The Palindrome chronic catheter is intended for acute and chronic hemodialys Terminated |
NYU | K123196 |
| Jul 1, 2015 | Covidien LLC Palindrome SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm
Item Code: 8888128458 Terminated |
NYU | K060972 K112477 |
| Jul 1, 2015 | Covidien LLC Palindrome SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm
Item Code: 8888128458 Terminated |
NYU | K060972 K112477 |
| Jul 1, 2015 | Covidien LLC Palindrome SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 23cm
Item Code: 8888123408 Terminated |
NYU | K060972 K112477 |
| Jul 1, 2015 | Covidien LLC Palindrome SI Chronic Catheter Kit 14.5 Fr x 55cm
Item Code: 8888145066C Terminated |
NYU | K060972 K112477 |
| Jul 1, 2015 | Covidien LLC Palindrome SI Chronic Catheter Kit 14.5 Fr x 55cm
Item Code: 8888145066 Terminated |
NYU | K060972 K112477 |
| Jul 1, 2015 | Covidien LLC Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm
Item Code: 8888145065C Terminated |
NYU | K060972 K112477 |
| Jul 1, 2015 | Covidien LLC Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm
Item Code: 8888145065 Terminated |
NYU | K060972 K112477 |
| Jul 1, 2015 | Covidien LLC Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm
Item Code: 8888145064C Terminated |
NYU | K060972 K112477 |
| Jul 1, 2015 | Covidien LLC Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm
Item Code:8888145064 Terminated |
NYU | K060972 K112477 |
| Jul 1, 2015 | Covidien LLC Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm
Item Code: 8888145063C Terminated |
NYU | K060972 K112477 |
| Jul 1, 2015 | Covidien LLC Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm
Item Code: 8888145063 Terminated |
NYU | K060972 K112477 |
| Jul 1, 2015 | Covidien LLC Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet
14.5 Fr x 19cm
Item Code: 8888145062C Terminated |
NYU | K060972 K112477 |
| Jul 1, 2015 | Covidien LLC Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet
14.5 Fr x 19cm
Item Code: 8888145062 Terminated |
NYU | K060972 K112477 |
| Jul 1, 2015 | Covidien LLC Palindrome SI Chronic Catheter Sport Pack 14.5 Fr x 33 cm
Item Code: 8888233508 Terminated |
NYU | K060972 K112477 |
| Jul 1, 2015 | Covidien LLC Palindrome SI Chronic Catheter Sport Pack 14.5 Fr x 28 cm
Item Code:8888228458 Terminated |
NYU | K060972 K112477 |
| Jul 1, 2015 | Covidien LLC Palindrome SI Chronic Catheter Sport Pack 14.5 Fr x 23 cm
Item Code: 8888223408 Terminated |
NYU | K060972 K112477 |
| Jul 1, 2015 | Covidien LLC Palindrome SI Chronic Catheter Kit 14.5 Fr x 28cm
Item Code: 8888245064 Terminated |
NYU | K060972 K112477 |
| Jul 1, 2015 | Covidien LLC Palindrome SI Chronic Catheter Kit 14.5 Fr x 28cm
Item Code: 8888245064 Terminated |
NYU | K060972 K112477 |
| Jul 1, 2015 | Covidien LLC Palindrome SI Chronic Catheter Kit 14.5 Fr x 28cm
Item Code: 8888245064 Terminated |
NYU | K060972 K112477 |
| Jul 1, 2015 | Covidien LLC Palindrome SI Chronic Catheter Kit 14.5 Fr x 23cm
Item Code: 8888245063 Terminated |
NYU | K060972 K112477 |
| Jul 1, 2015 | Covidien LLC Palindrome SI Chronic Catheter Kit 14.5 Fr x 19cm
Item Code: 8888245062
The Palindrome SI Chronic Catheter is indicated for acute and chronic hemodialysis, apheresis, and infusion. Terminated |
NYU | K060972 K112477 |
| Dec 4, 2008 | Covidien PALINDROME EMERALD Kit - Cuffed Dual Lumen Catheter with Pre-cuffed Shaft and Heparin Coating, REF 8888145070, 14.5 FR/CH (4.85mm) x 28 cm. TYCO HEALTHCARE GROUP LP, Mansfield, MA 02048. --- NOTE: B Terminated |
NYU | K051584 K060509 |
| Dec 4, 2008 | Covidien PALINDROME EMERALD Kit - Cuffed Dual Lumen Catheter with Pre-curved Shaft and Heparin Coating, REF 8888145069, 14.5 Fr/CH (4.85mm) x 23cm. TYCO HEALTHCARE GROUP LP, Mansfield, MA 02048. --- NOTE: Bot Terminated |
NYU | K051584 K060509 |
| Dec 4, 2008 | Covidien PALINDROME EMERALD SPORT PACK Cuffed Dual Lumen Catheter with Pre-curved Shaft and Heparin Coating, REF 8888128461, Size 14.5Fr/Ch (4.85mm) x 28cm. TYCO HEALTHCARE GROUP LP, Mansfield, MA 02048. --- Terminated |
NYU | K051584 K060509 |
| Dec 4, 2008 | Covidien PALINDROME EMERALD SPORT PACK Cuffed Dual Lumen Catheter with Pre-curved Shaft and Heparin Coating, REF 8888123411, Size 14.5Fr/Ch (4.85mm) x 23cm. TYCO HEALTHCARE GROUP LP, Mansfield, MA 02048. --- Terminated |
NYU | K051584 K060509 |
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