C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge
FDA 510(k) clearance K203024 · decided 2020-11-24
Clearance details
- K-number
- K203024
- Device name
- C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge
- Applicant
- Pentax of America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-10-02
- Decision date
- 2020-11-24
- Days to decision
- 53 days
- Clearance type
- Traditional
- Product code
- GEH
- Device class
- 2
- Regulation number
- 878.4350
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Redwood, Ca, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.