TAL PALLINDROME (TM) SYMMETRIC TIP DUAL LUMEN CATHETER, MAHURKAR (R) MAXID (TM) DUAL LUMEN CATHETER, PALINDROME (TM)...— 510(k) K111372
UnknownCovidien
FDA 510(k) clearance K111372 for TAL PALLINDROME (TM) SYMMETRIC TIP DUAL LUMEN CATHETER, MAHURKAR (R) MAXID (TM) DUAL LUMEN CATHETER, PALINDROME (TM)..., Unknown on 2011-08-04. 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 K111372
K-number listed on FDA's recall record- Z-2632-2023 — Palindrome Chronic Catheter Kit Symmetrical Tip14.5 Fr/Ch(4.8mm)x23cm
- Z-1316-2022 — Palindrome Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.
- Z-1320-2022 — Mahurkar Chronic Carbothane (Maxid) Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K111372.
Data sourced from openFDA. This site is unofficial and independent of the FDA.