PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER
FDA 510(k) clearance K871080 · decided 1987-08-12
Clearance details
- K-number
- K871080
- Device name
- PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER
- Applicant
- Catheter Technology Corp.
- Decision
- Substantially Equivalent
- Date received
- 1987-03-18
- Decision date
- 1987-08-12
- Days to decision
- 147 days
- Clearance type
- Traditional
- Product code
- DQY
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Salt Lake City, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: Groshong Mi recall (Z-1275-2015) | Bard Access Systems | 2015-03-13 |