FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SILVERTORQUE CEREBRAL CATHETER
K Number: K840762
·
Decision Jul 13, 1984
Classifications
1
FEI Numbers
276
Registration Numbers
277
Same Product Code
889
Applicant Total
5
Review Days
141
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Basic Information
- Device Name
- SILVERTORQUE CEREBRAL CATHETER
- K Number
- K840762
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Surgimed Corp.
- Date Received
- February 23, 1984
- Decision Date
- July 13, 1984
- Product Code
- DQY
- 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 |
|---|---|---|---|
| DQY | Catheter, Percutaneous | FDA class 2 | Cardiovascular |
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Other Clearances by Surgimed Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K851157 | SURGIMED - SURGICAL BLADES | Apr 25, 1985 | Substantially Equivalent |
| K840763 | SILVERTORQUE CARDIAC CATHETERS | Jun 13, 1984 | Substantially Equivalent |
| K840761 | SILVERTORQUE VISCERAL CATHETER | Jun 11, 1984 | Substantially Equivalent |
| K810689 | BALLOON CATHETER | Jul 28, 1981 | Substantially Equivalent |