MINI-VOL EXTENSION SET
FDA 510(k) clearance K831087 · decided 1983-04-28
Clearance details
- K-number
- K831087
- Device name
- MINI-VOL EXTENSION SET
- Applicant
- Beech Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-04-04
- Decision date
- 1983-04-28
- Days to decision
- 24 days
- Clearance type
- Traditional
- Product code
- FPA
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Beech Medical
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.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Low Volume Extension Set, 72' w/Clamp FLL/MLL APV=1.3ml, STERILE, AND FLUID PATH NONPYROGE recall (Z-1730-2015) | Smiths Medical Asd Inc | 2015-06-08 |