CHARLIE GUIDEWIRE (REGULAR), CHARLIE GUIDEWIRE (STIFF)
FDA 510(k) clearance K121398 · decided 2012-12-13
Clearance details
- K-number
- K121398
- Device name
- CHARLIE GUIDEWIRE (REGULAR), CHARLIE GUIDEWIRE (STIFF)
- Applicant
- Guidepath Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-05-09
- Decision date
- 2012-12-13
- Days to decision
- 218 days
- Clearance type
- Traditional
- Product code
- DQX
- Device class
- 2
- Regulation number
- 870.1330
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Guidepath Medical
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.