PALINDROME RT CHRONIC CATHETER— 510(k) K111817
UnknownCovidien
FDA 510(k) clearance K111817 for PALINDROME RT CHRONIC CATHETER, Unknown on 2011-08-30. Applicant: Covidien. Device class: 2.
Clearance details
- Applicant
- Covidien
- Product code
- Code MSD
- 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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Adverse events under product code MSD
product code MSD- Death
- 67
- Injury
- 545
- Malfunction
- 3,661
- Total
- 4,273
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K111817
K-number listed on FDA's recall record- Z-2358-2021 — Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 19 cm, Item Code 8888541019
- Z-2359-2021 — Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 23 cm, Item Code 8888541023
- Z-2360-2021 — Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 28 cm, Item Code 8888541028
- Z-2361-2021 — Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 33cm, Item Code 8888541033
- Z-2362-2021 — Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 44cm, Item Code 8888541044
- Z-2363-2021 — Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 55cm, Item Code 8888541055
- Z-2364-2021 — Palindrome RT Repair Kit 15 FR TAL 19cm, Sterile, Item Code 8888541119
- Z-2365-2021 — Palindrome RT Repair Kit 15 FR TAL 23cm, Sterile, Item Code 8888541123
- Z-2366-2021 — Palindrome RT Repair Kit 15 FR TAL 28cm, Sterile, Item Code 8888541128
- Z-2367-2021 — Palindrome RT Repair Kit 15 FR TAL 33cm, Sterile, Item Code 8888541133
- Z-2368-2021 — Palindrome RT Repair Kit 15 FR TAL 44cm, Sterile, Item Code 8888541144
- Z-2369-2021 — Palindrome RT Repair Kit 15 FR TAL 55cm, Sterile, Item Code 8888541155
- Z-2370-2021 — Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 19 cm, Item Code 8888541019P
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K111817.
Data sourced from openFDA. This site is unofficial and independent of the FDA.