INTROCAN SAFETY IV CATHETER
FDA 510(k) clearance K020785 · decided 2002-08-28
Clearance details
- K-number
- K020785
- Device name
- INTROCAN SAFETY IV CATHETER
- Applicant
- B.Braun Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-03-11
- Decision date
- 2002-08-28
- Days to decision
- 170 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
+ Add to Predicate Builder ◉ Watch B.Braun Medical
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle devic recall (Z-0009-2023) | B Braun Medical Inc | 2022-10-06 |
| 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 |