CATHLAB SILICONE BILIARY BALLOON CATHETER— 510(k) K910917
Substantially EquivalentCathlab Corp.
FDA 510(k) clearance K910917 for CATHLAB SILICONE BILIARY BALLOON CATHETER, Substantially Equivalent on 1991-08-02. Applicant: Cathlab Corp.. Device class: 2.
Clearance details
- Applicant
- Cathlab Corp.
- Product code
- Code GCA
- Device class
- Class 2
- Regulation
- 21 CFR 876.5010
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
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More clearances from Cathlab Corp.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.