INTERCEPT ESOPHAGEAL INTERNAL MR COIL, INTERCEPT URETHRAL INTERNAL MR COIL, AND INTERCEPT VASCULAR INTERNAL MR COIL
FDA 510(k) clearance K020495 · decided 2002-04-23
Clearance details
- K-number
- K020495
- Device name
- INTERCEPT ESOPHAGEAL INTERNAL MR COIL, INTERCEPT URETHRAL INTERNAL MR COIL, AND INTERCEPT VASCULAR INTERNAL MR COIL
- Applicant
- Surgi-Vision, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-02-14
- Decision date
- 2002-04-23
- Days to decision
- 68 days
- Clearance type
- Traditional
- Product code
- MOS
- Device class
- 2
- Regulation number
- 892.1000
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Gaithersburg, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.