FLEXCATH STEERABLE SHEATH & DILATOR
FDA 510(k) clearance K070357 · decided 2007-12-28
Clearance details
- K-number
- K070357
- Device name
- FLEXCATH STEERABLE SHEATH & DILATOR
- Applicant
- Cryocath Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-02-07
- Decision date
- 2007-12-28
- Days to decision
- 324 days
- Clearance type
- Traditional
- Product code
- DRA
- Device class
- 2
- Regulation number
- 870.1280
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Santa Fe, NM, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.