FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FINESSE GUIDEWIRE CORONARY
K Number: K952430
·
Decision Aug 18, 1995
Classifications
1
FEI Numbers
257
Registration Numbers
258
Same Product Code
763
Applicant Total
20
Review Days
86
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Basic Information
- Device Name
- FINESSE GUIDEWIRE CORONARY
- K Number
- K952430
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1330
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Flexmedics
- Date Received
- May 24, 1995
- Decision Date
- August 18, 1995
- 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 Flexmedics
| K Number | Device Name | ||
|---|---|---|---|
| K990765 | FLEXFINDER GUIDE WIRE(REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS, FLEXFINDER GUIDE WIRE (REGULAR SHAFT/STIFF SHAFT) NO | Mar 15, 1999 | Substantially Equivalent |
| K964955 | FLEXFINDER GUIDEWIRE (REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS ENCAP+/GUIDEWIRE(REGULAR SHAFT/STIFF SHAFT) NO MARKING | Feb 14, 1997 | Substantially Equivalent |
| K943390 | FLEXFINDER GUIDEWIRE | Jun 27, 1995 | Substantially Equivalent |
| K942074 | FLEXFINDER GUIDEWIRE | Jun 24, 1994 | Substantially Equivalent |
| K934265 | FLEXMEDICS SUPER-SEVEN STRANDED NICKEL-TITANIUM ARCHWIRE | Jan 21, 1994 | Substantially Equivalent |
| K912843 | FLEXMEDICS RETRACT ORTH PROBE, PETTINE BONE PROBE | Sep 24, 1991 | Substantially Equivalent |
| K910674 | FLEXMEDICS MALLEABLE CANNULA | Apr 12, 1991 | Substantially Equivalent |
| K895899 | FLEXMEDICS GUIDEWIRE .012 ONLY | May 23, 1990 | Substantially Equivalent |
| K893626 | FLEXMEDICS GUIDEWIRE | Sep 26, 1989 | Substantially Equivalent |
| K885086 | TIN COATED NITI ORTHODONTIC ARCH WIRES | Jan 10, 1989 | Substantially Equivalent |