MODEL 675GE-64 PERIPHERAL VASCULAR COIL CONSISTING OF MODEL 665GE-64: LOWER EXTREMITY FLEXIBLE ARRAY AND MODEL 538GE-64:
FDA 510(k) clearance K964813 · decided 1997-02-26
Clearance details
- K-number
- K964813
- Device name
- MODEL 675GE-64 PERIPHERAL VASCULAR COIL CONSISTING OF MODEL 665GE-64: LOWER EXTREMITY FLEXIBLE ARRAY AND MODEL 538GE-64:
- Applicant
- Medical Advances, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-11-29
- Decision date
- 1997-02-26
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- MOS
- Device class
- 2
- Regulation number
- 892.1000
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Milwaukee, WI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.