PTI INTRA-ARTR REUSABLE CORONARY ARTERY PROBE
FDA 510(k) clearance K901531 · decided 1990-06-20
Clearance details
- K-number
- K901531
- Device name
- PTI INTRA-ARTR REUSABLE CORONARY ARTERY PROBE
- Applicant
- Pioneering Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-03-22
- Decision date
- 1990-06-20
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- DNP
- Device class
- 2
- Regulation number
- 862.3380
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Wheat Ridge, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.