FDA 510(k)
Substantially Equivalent
🇺🇸 United States
BALLOON CATHETER
K Number: K810689
·
Decision Jul 28, 1981
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
5
Review Days
137
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Basic Information
- Device Name
- BALLOON CATHETER
- K Number
- K810689
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Surgimed Corp.
- Date Received
- March 13, 1981
- Decision Date
- July 28, 1981
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
Other Clearances by Surgimed Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K851157 | SURGIMED - SURGICAL BLADES | Apr 25, 1985 | Substantially Equivalent |
| K840762 | SILVERTORQUE CEREBRAL CATHETER | Jul 13, 1984 | Substantially Equivalent |
| K840763 | SILVERTORQUE CARDIAC CATHETERS | Jun 13, 1984 | Substantially Equivalent |
| K840761 | SILVERTORQUE VISCERAL CATHETER | Jun 11, 1984 | Substantially Equivalent |