FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CORDIS WEBSTER REF-STAR EX SURFACE REFERENCE DEVICE MODEL'S D-1204-01, -02,-03, AND -04.
K Number: K980961
·
Decision May 28, 1998
Classifications
1
FEI Numbers
86
Registration Numbers
86
Same Product Code
182
Applicant Total
10
Review Days
73
Basic Information
- Device Name
- CORDIS WEBSTER REF-STAR EX SURFACE REFERENCE DEVICE MODEL'S D-1204-01, -02,-03, AND -04.
- K Number
- K980961
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1220
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- CORDIS WEBSTER, INC.
- Date Received
- March 16, 1998
- Decision Date
- May 28, 1998
- Product Code
- DRF
- Advisory Committee
- Cardiovascular
- 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 |
|---|---|---|---|
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | FDA class 2 | Cardiovascular |
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Other Clearances by CORDIS WEBSTER, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K992965 | CORDIS WEBSTER FIXED CURVE CATHETERS, MODELS D-1124, D-1085 | Nov 26, 1999 | Substantially Equivalent |
| K991531 | CORDIS WEBSTER DIAGNOSTIC DEFLECTABLE TIP CATHETER, MODEL D-1078 | Oct 4, 1999 | Substantially Equivalent |
| K982740 | CORDIS WEBSTER PREFACE BRAIDED GUIDING SHEATH & PERRY EXCHANGE DILATOR, MODEL #'S 301-803A, 301-803P, 301-803M, 301-813S | Aug 28, 1998 | Substantially Equivalent |
| K982415 | CORDIS WEBSTER REF-STAR EXTERNAL REFERENCE PATCH, MODEL # D-1210 | Aug 10, 1998 | Substantially Equivalent |
| K970264 | CORDIS WEBSTER BRAIDED GUIDING SHEATH EXCHANGE SYSTEM | Oct 28, 1997 | Substantially Equivalent |
| K953663 | CORDIS WEBSTER T20 DIAGNOSTIC DEFLECTABLE TIP CATHETER | Sep 18, 1996 | Substantially Equivalent |
| K955817 | CORIDIS WEBSTER DEFLECTABLE BRAIDED-TIP ELECTRODE CATHETER | Mar 25, 1996 | Substantially Equivalent |
| K954390 | CORDIS WESTER STAR CATHETER | Dec 21, 1995 | Substantially Equivalent |
| K953768 | CORDIS WEBSTER A20 DIAGNOSTIC DEFLECTABLE TIP CATHETER | Nov 22, 1995 | Substantially Equivalent |