FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
4.5F IMAGECATH CORONARY ANGIOSCOPE, MODEL COV45 [SUBSEQUENTLY REFERRED TO AS THE MODIFIED ANGIOSCOPE[
K Number: K952638
·
Decision Jul 28, 1995
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
40
Applicant Total
11
Review Days
49
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Basic Information
- Device Name
- 4.5F IMAGECATH CORONARY ANGIOSCOPE, MODEL COV45 [SUBSEQUENTLY REFERRED TO AS THE MODIFIED ANGIOSCOPE[
- K Number
- K952638
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Baxter Edwards
- Date Received
- June 9, 1995
- Decision Date
- July 28, 1995
- Product Code
- LYK
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LYK | Angioscope | FDA class 2 | Gastroenterology, Urology |
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|---|---|---|---|
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| K965137 | FOGARTY VALVULOTOME MODEL 700091 | Jun 4, 1997 | Substantially Equivalent |
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| K955839 | MULTI-MED MULTI-LUMEN CENTRAL VENOUS CATHETER | Mar 25, 1996 | Substantially Equivalent |
| K944214 | BAXTER HANDLE MODEL 1150 | Feb 10, 1995 | Substantially Equivalent |
| K944858 | BAXTER EPTFE EXTERNALLY SUPPORTED VASCULAR GRAFTS | Jan 5, 1995 | Substantially Equivalent - Subject to Tracking Reg. |
| K940795 | SWAN-GANZ CC0/SVO2 THERMODILUTION CATHETER | May 24, 1994 | Substantially Equivalent |
| K926433 | 4.5F IMAGECATH(R) CORONARY ANGIOSCOPE, COV45 | Mar 23, 1993 | Substantially Equivalent |