VERSACATH(TM) SELECTALUMEN(TM) W/CONVERSION TRAY
FDA 510(k) clearance K910565 · decided 1991-06-03
Clearance details
- K-number
- K910565
- Device name
- VERSACATH(TM) SELECTALUMEN(TM) W/CONVERSION TRAY
- Applicant
- Menlo Care, Inc.
- Decision
- Unknown
- Date received
- 1991-02-08
- Decision date
- 1991-06-03
- Days to decision
- 115 days
- Clearance type
- Traditional
- Product code
- FOZ
- Device class
- 2
- Regulation number
- 880.5200
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Menlo Park, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Menlo Care
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.