MEDCOMP BIO-FLEX CS CATHETER (CS100)
FDA 510(k) clearance K971925 · decided 1998-02-23
Clearance details
- K-number
- K971925
- Device name
- MEDCOMP BIO-FLEX CS CATHETER (CS100)
- Applicant
- Medical Components, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-05-23
- Decision date
- 1998-02-23
- Days to decision
- 276 days
- Clearance type
- Traditional
- 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 |
|---|---|---|
| Medcomp, 10F Bioflex Tesio Kit with cutting trocar. Catalog number BFR-6CTT 5 per box. Hem recall (Z-0161-2010) | Medical Components, Inc dba MedComp | 2009-11-10 |