ALL-VUE ULTRA-LITE THIN WALL SYRINGE SHIELD
FDA 510(k) clearance K934549 · decided 1994-02-19
Clearance details
- K-number
- K934549
- Device name
- ALL-VUE ULTRA-LITE THIN WALL SYRINGE SHIELD
- Applicant
- Victoreen, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-09-22
- Decision date
- 1994-02-19
- Days to decision
- 150 days
- Clearance type
- Traditional
- Product code
- IWR
- Device class
- 1
- Regulation number
- 892.6500
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Cleveland, OH, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Victoreen
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| LEAD GLASS SHIELDS (K872656) | Viox Corp. | 1987-07-16 |
| DUFFY BOLUS INJECTOR (K863936) | Viox Corp. | 1987-01-06 |
| TUNGSTEN SYRINGE SHIELD (K811688) | Medi-Physics Inc. Dba Nycomed Amersham Imaging | 1981-07-02 |
Recalls involving this device
No recalls on record reference this clearance.