PALINDROME H, SI, HSI CHRONIC CATHETER— 510(k) K112477
UnknownCovidien
FDA 510(k) clearance K112477 for PALINDROME H, SI, HSI CHRONIC CATHETER, Unknown on 2011-09-28. Applicant: Covidien. Device class: 2.
Clearance details
- Applicant
- Covidien
- Product code
- Code NYU
- Device class
- Class 2
- Regulation
- 21 CFR 876.5540
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Special
- Location
- Mansfield, MA, US
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Recalls naming K112477
K-number listed on FDA's recall record- Z-1317-2022 — Palindrome H Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
- Z-1318-2022 — Palindrome SI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
- Z-1319-2022 — Palindrome HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
- Z-1850-2015 — 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.
- Z-1851-2015 — Palindrome SI Chronic Catheter Kit 14.5 Fr x 23cm Item Code: 8888245063
- Z-1852-2015 — Palindrome SI Chronic Catheter Kit 14.5 Fr x 28cm Item Code: 8888245064
- Z-1853-2015 — Palindrome SI Chronic Catheter Kit 14.5 Fr x 28cm Item Code: 8888245064
- Z-1854-2015 — Palindrome SI Chronic Catheter Kit 14.5 Fr x 28cm Item Code: 8888245064
- Z-1857-2015 — Palindrome SI Chronic Catheter Sport Pack 14.5 Fr x 33 cm Item Code: 8888233508
- Z-1858-2015 — Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145062
- Z-1859-2015 — Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145062C
- Z-1860-2015 — Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145063
- Z-1861-2015 — Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145063C
- Z-1862-2015 — Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code:8888145064
- Z-1863-2015 — Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145064C
- Z-1864-2015 — Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145065
- Z-1865-2015 — Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145065C
- Z-1866-2015 — Palindrome SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 8888145066
- Z-1867-2015 — Palindrome SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 8888145066C
- Z-1868-2015 — Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145062P
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K112477.
Data sourced from openFDA. This site is unofficial and independent of the FDA.