CAPSULS, MODELS 2003-PUR8C, 2004-PVC8C
FDA 510(k) clearance K052798 · decided 2006-06-06
Clearance details
- K-number
- K052798
- Device name
- CAPSULS, MODELS 2003-PUR8C, 2004-PVC8C
- Applicant
- Isovac Products, LLC
- Decision
- Substantially Equivalent
- Date received
- 2005-10-03
- Decision date
- 2006-06-06
- Days to decision
- 246 days
- Clearance type
- Traditional
- Product code
- LGN
- Device class
- 2
- Regulation number
- 880.5450
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Bellaire, TX, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Isovac Products
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
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 |
|---|---|---|
| AIRCRAFT TRANSIT ISOLATOR MODEL 121 (K790658) | Vickers America Medical Corp. | 1979-07-03 |
Recalls involving this device
No recalls on record reference this clearance.