4.5F IMAGECATH CORONARY ANGIOSCOPE, MODEL COV45 [SUBSEQUENTLY REFERRED TO AS THE MODIFIED ANGIOSCOPE[
FDA 510(k) clearance K952638 · decided 1995-07-28
Clearance details
- K-number
- K952638
- Device name
- 4.5F IMAGECATH CORONARY ANGIOSCOPE, MODEL COV45 [SUBSEQUENTLY REFERRED TO AS THE MODIFIED ANGIOSCOPE[
- Applicant
- Baxter Edwards
- Decision
- Substantially Equivalent
- Date received
- 1995-06-09
- Decision date
- 1995-07-28
- Days to decision
- 49 days
- Clearance type
- Traditional
- Product code
- LYK
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Santa Ana, CA, US
- Third-party review
- No
- Expedited review
- No
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| APPLIED MEDICAL 1.5MM REUSABLE ANGIOSCOPE (K951721) | Applied Medical Resources | 1995-07-11 |
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| ANGIOSCOPE (K934696) | Intramed Laboratories, Inc. | 1994-01-18 |
Recalls involving this device
No recalls on record reference this clearance.