INTROCAN SAFETY IV CATHETER
FDA 510(k) clearance K982805 · decided 1999-01-14
Clearance details
- K-number
- K982805
- Device name
- INTROCAN SAFETY IV CATHETER
- Applicant
- B.Braun Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-08-10
- Decision date
- 1999-01-14
- Days to decision
- 157 days
- Clearance type
- Traditional
- Product code
- FOZ
- Device class
- 2
- Regulation number
- 880.5200
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Bethlehem, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Introcan Safety IV Catheter 22G x 1'' PUR with Wings. The affected catalogs and lot number recall (Z-1092-04) | Braun,B Medical Inc | 2004-07-20 |