Edi Catheter ENFit
FDA 510(k) clearance K153688 · decided 2017-03-02
Clearance details
- K-number
- K153688
- Device name
- Edi Catheter ENFit
- Applicant
- Maquet Critical Care AB
- Decision
- Substantially Equivalent
- Date received
- 2015-12-23
- Decision date
- 2017-03-02
- Days to decision
- 435 days
- Clearance type
- Traditional
- Product code
- PIF
- Device class
- 2
- Regulation number
- 876.5980
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Solna, SE
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Maquet Critical Care AB
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
No recalls on record reference this clearance.