CATHSCANNER(R) INTRAVASCULAR ULTRA IMAGING SYSTEM
FDA 510(k) clearance K893042 · decided 1989-07-19
Clearance details
- K-number
- K893042
- Device name
- CATHSCANNER(R) INTRAVASCULAR ULTRA IMAGING SYSTEM
- Applicant
- Endosonics Corp.
- Decision
- Substantially Equivalent
- Date received
- 1989-04-24
- Decision date
- 1989-07-19
- Days to decision
- 86 days
- Clearance type
- Traditional
- Product code
- IYN
- Device class
- 2
- Regulation number
- 892.1550
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Rancho Cordova, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.