CBIS CATHETER PULL-BACK DEVICE
FDA 510(k) clearance K921879 · decided 1992-07-16
Clearance details
- K-number
- K921879
- Device name
- CBIS CATHETER PULL-BACK DEVICE
- Applicant
- Cardiovascular Imaging Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-04-20
- Decision date
- 1992-07-16
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- DQO
- Device class
- 2
- Regulation number
- 870.1200
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Sunnyvale, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Cardiovascular Imaging Systems
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.