HEMOSTASIS VALVE
FDA 510(k) clearance K895214 · decided 1989-11-14
Clearance details
- K-number
- K895214
- Device name
- HEMOSTASIS VALVE
- Applicant
- Applied Vascular Devices, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-08-18
- Decision date
- 1989-11-14
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- DYB
- Device class
- 2
- Regulation number
- 870.1340
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Laguna Hills, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Applied Vascular Devices
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.