MEDISYSTEMS HEMODIALYSIS FISTULA SET
FDA 510(k) clearance K910734 · decided 1991-06-20
Clearance details
- K-number
- K910734
- Device name
- MEDISYSTEMS HEMODIALYSIS FISTULA SET
- Applicant
- Medisystems Corp.
- Decision
- Substantially Equivalent
- Date received
- 1991-02-21
- Decision date
- 1991-06-20
- Days to decision
- 119 days
- Clearance type
- Traditional
- Product code
- FIE
- Device class
- 2
- Regulation number
- 876.5540
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- San Francisco, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Medisystems Corp.
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
| Record | Firm | Date |
|---|---|---|
| Medisystems 17 Gauge x 1" inch AV Fistula Needle Product Code: D9-2007MGLB Product Usage: recall (Z-0715-2013) | Medisystems a NX Stage Company | 2013-01-24 |
| Medisystems (a Nxstage Company) Hemodialysis Fistula Needle Set with MasterGuard Ant-Stick recall (Z-1126-2012) | Medisystems Corp | 2012-02-29 |