ARROW PICC-PERIPHERALLY INSERTED CENTRAL CATHETER
FDA 510(k) clearance K930129 · decided 1994-03-28
Clearance details
- K-number
- K930129
- Device name
- ARROW PICC-PERIPHERALLY INSERTED CENTRAL CATHETER
- Applicant
- Arrow Intl., Inc.
- Decision
- Unknown
- Date received
- 1993-01-12
- Decision date
- 1994-03-28
- Days to decision
- 440 days
- Clearance type
- Traditional
- Product code
- LJS
- Device class
- 2
- Regulation number
- 880.5970
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Reading, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Arrow PICC Kit with Blue Flex Tip Catheter and Placement Wire. Catalog number PK-01552-WSS recall (Z-0551-05) | Arrow International Inc | 2005-02-18 |
| Arrow PICC Two Lumen Peripherally Inserted Central Catheter Set with Blue FlexTip Catheter recall (Z-0552-05) | Arrow International Inc | 2005-02-18 |