DIACAP LO PS (10, 12, 15) AND DIACAP HI PS (10, 12, 15, 18, 20) HEMODIALYZERS
FDA 510(k) clearance K071518 · decided 2007-08-17
Clearance details
- K-number
- K071518
- Device name
- DIACAP LO PS (10, 12, 15) AND DIACAP HI PS (10, 12, 15, 18, 20) HEMODIALYZERS
- Applicant
- B. Braun Medizintechnologie GmbH
- Decision
- Substantially Equivalent
- Date received
- 2007-06-04
- Decision date
- 2007-08-17
- Days to decision
- 74 days
- Clearance type
- Traditional
- Product code
- KDI
- Device class
- 2
- Regulation number
- 876.5860
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Melsungen, DE
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch B. Braun Medizintechnologie GmbH
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.
Recalls involving this device
No recalls on record reference this clearance.