FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SCIMED 0.014 PTCA GUIDE WIRE WITH ICE HYDROPHILIC COATING
K Number: K941895
·
Decision May 24, 1994
Classifications
1
FEI Numbers
257
Registration Numbers
258
Same Product Code
763
Applicant Total
109
Review Days
36
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Basic Information
- Device Name
- SCIMED 0.014 PTCA GUIDE WIRE WITH ICE HYDROPHILIC COATING
- K Number
- K941895
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1330
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Scimed Life Systems, Inc.
- Date Received
- April 18, 1994
- Decision Date
- May 24, 1994
- Product Code
- DQX
- 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 |
|---|---|---|---|
| DQX | Wire, Guide, Catheter | FDA class 2 | Cardiovascular |
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Other Clearances by Scimed Life Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K974241 | SCIMED INFORMER PRESSURE WIRE SYSTEM | Nov 12, 1998 | Substantially Equivalent |
| K981788 | SCIMED 6 FRENCH WISEGUIDE GUIDE CATHETER | Aug 18, 1998 | Substantially Equivalent |
| K980360 | SCIMED QUEST FLOPPY AND MODERATE SUPPORT GUIDE WIRES | Apr 29, 1998 | Substantially Equivalent |
| K974559 | SCIMED 6 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS | Feb 23, 1998 | Substantially Equivalent |
| K974684 | SCIMED 7 FRENCH WISEGUIDE GUIDE CATHETER | Feb 19, 1998 | Substantially Equivalent |
| K973945 | LUGE GUIDE WIRE | Jan 12, 1998 | Substantially Equivalent |
| K970823 | SCIMED 8 FRENCH WISEGUIDE GUIDE CATHETER | Jun 3, 1997 | Substantially Equivalent |
| K964551 | CHOICE SUPER SUPPORT PTCA GUIDE WIRE, CHOICE PLUS SUPER SUPPORT PTCA GUIDE WIRE, CHOICE EXCHANGE SUPER SUPPORT PTCA GUID | May 21, 1997 | Substantially Equivalent |
| K970244 | SCIMED CHOICE FAMILY OF PTCA GUIDE WIRES | Mar 28, 1997 | Substantially Equivalent |
| K965023 | CHOICE PT PLUS PTCA GUIDE WIRE AND CHOICE PT VISION PTCA GUIDE WIRE | Mar 4, 1997 | Substantially Equivalent |