CENTRAL VEIN CATHETERIZATION TRAY
FDA 510(k) clearance K852642 · decided 1986-01-16
Clearance details
- K-number
- K852642
- Device name
- CENTRAL VEIN CATHETERIZATION TRAY
- Applicant
- Teleflexmedical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-06-21
- Decision date
- 1986-01-16
- Days to decision
- 209 days
- Clearance type
- Traditional
- Product code
- FDZ
- Device class
- 1
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Jeffrey, NH, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| EXEL INDWELLING CATHETER (K895772) | Exel Intl. | 1990-02-16 |
Recalls involving this device
No recalls on record reference this clearance.