FDA 510(k)
Substantially Equivalent
🇺🇸 United States
FLEXMEDICS NITINOL MAMMORY WIRE
K Number: K870156
·
Decision Feb 24, 1987
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
20
Review Days
42
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Basic Information
- Device Name
- FLEXMEDICS NITINOL MAMMORY WIRE
- K Number
- K870156
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Flexmedics
- Date Received
- January 13, 1987
- Decision Date
- February 24, 1987
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
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 |
| K952430 | FINESSE GUIDEWIRE CORONARY | Aug 18, 1995 | 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 |