3.0 FR GROSHONG PERIPHER INSERT CENT VENOUS CATH
FDA 510(k) clearance K926331 · decided 1994-03-07
Clearance details
- K-number
- K926331
- Device name
- 3.0 FR GROSHONG PERIPHER INSERT CENT VENOUS CATH
- Applicant
- Bard Access Systems, Inc.
- Decision
- Unknown
- Date received
- 1992-12-16
- Decision date
- 1994-03-07
- Days to decision
- 446 days
- Clearance type
- Traditional
- Product code
- LJS
- Device class
- 2
- Regulation number
- 880.5970
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Salt Lake City, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Groshong 3 Fr. Single-Lumen PICC Intermediate Tray with Safety Introducer, Reorder Number recall (Z-0865-2011) | Bard Access Systems | 2011-01-06 |