GUIDE-TECH ENCAPSULATED GUIDEWIRE
FDA 510(k) clearance K926039 · decided 1993-08-05
Clearance details
- K-number
- K926039
- Device name
- GUIDE-TECH ENCAPSULATED GUIDEWIRE
- Applicant
- Cape Tech Medical Products
- Decision
- Substantially Equivalent
- Date received
- 1992-12-01
- Decision date
- 1993-08-05
- Days to decision
- 247 days
- Clearance type
- Traditional
- Product code
- KNY
- Device class
- 2
- Regulation number
- 876.5130
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Falmouth, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.