SPLIT CATH III 24CM SPLIT CATH III 24CM SPLIT CATH III 32CM CATH III 36CM SPLIT CATH III 40CM AND 55CM
FDA 510(k) clearance K121848 · decided 2012-09-21
Clearance details
- K-number
- K121848
- Device name
- SPLIT CATH III 24CM SPLIT CATH III 24CM SPLIT CATH III 32CM CATH III 36CM SPLIT CATH III 40CM AND 55CM
- Applicant
- Medical Components, Inc.
- Decision
- Unknown
- Date received
- 2012-06-25
- Decision date
- 2012-09-21
- Days to decision
- 88 days
- Clearance type
- Special
- Product code
- MSD
- Device class
- 2
- Regulation number
- 876.5540
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Harleysville, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Split Cath III Trays, 16F x 28CM Product Usage: The Split Cath III is indicated for use in recall (Z-2592-2014) | Medical Components, Inc dba MedComp | 2014-09-04 |