SPLIT CATH III 24CM SPLIT CATH III 24CM SPLIT CATH III 32CM CATH III 36CM SPLIT CATH III 40CM AND 55CM— 510(k) K121848
UnknownMedical Components, Inc.
FDA 510(k) clearance K121848 for SPLIT CATH III 24CM SPLIT CATH III 24CM SPLIT CATH III 32CM CATH III 36CM SPLIT CATH III 40CM AND 55CM, Unknown on 2012-09-21. Applicant: Medical Components, Inc.. Device class: 2.
Clearance details
- Applicant
- Medical Components, Inc.
- 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
- Harleysville, PA, US
Recent devices under product code MSD
view allMore clearances from Medical Components, Inc.
view allAdverse 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 K121848
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K121848.
Data sourced from openFDA. This site is unofficial and independent of the FDA.