CG+ ARROW JACC POWERED BY ARROW VPS STYLET
FDA 510(k) clearance K132133 · decided 2013-09-26
Clearance details
- K-number
- K132133
- Device name
- CG+ ARROW JACC POWERED BY ARROW VPS STYLET
- Applicant
- Arrow International (Subsidiary of Teleflex Inc.)
- Decision
- Substantially Equivalent
- Date received
- 2013-07-11
- Decision date
- 2013-09-26
- Days to decision
- 77 days
- Clearance type
- Special
- Product code
- OBJ
- Device class
- 2
- Regulation number
- 870.1200
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Reading, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Description/REF: PI JACC KIT: 2L 5.5 FR X 15 CM CG+/ASK-41552-LTAC; PI JACC KIT: 3L 6 FR X recall (Z-2379-2026) | ARROW INTERNATIONAL, LLC | 2026-06-13 |
| ARROW PICC Kit featuring Chlorag+ard Technology Midline Catheterization Kit ARROW Advantag recall (Z-0207-2016) | Arrow International Inc | 2015-11-04 |