INTROCAN SAFETY IV CATHETER
FDA 510(k) clearance K021094 · decided 2002-07-03
Clearance details
- K-number
- K021094
- Device name
- INTROCAN SAFETY IV CATHETER
- Applicant
- B.Braun Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-04-04
- Decision date
- 2002-07-03
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- DYB
- Device class
- 2
- Regulation number
- 870.1340
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Allentown, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| B. Braun Introcan Safety IV Catheter PUR 24G, 0.7X19mm-US, catalog number 4251601-02. Prod recall (Z-0559-2014) | B. Braun Medical, Inc. | 2013-12-21 |