FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SAFESEPT TRANSSEPTAL TROCAR GUIDEWIRE
K Number: K081986
·
Decision Nov 14, 2008
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
50
Applicant Total
49
Review Days
123
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Basic Information
- Device Name
- SAFESEPT TRANSSEPTAL TROCAR GUIDEWIRE
- K Number
- K081986
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1390
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Oscor, Inc.
- Date Received
- July 14, 2008
- Decision Date
- November 14, 2008
- Product Code
- DRC
- 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 |
|---|---|---|---|
| DRC | Trocar | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
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| K130104 | GUIDEWIRE, PURSUER SERIES | Jun 13, 2013 | Substantially Equivalent |
| K122960 | STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO | Dec 13, 2012 | Substantially Equivalent |
| K122958 | DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY | Dec 13, 2012 | Substantially Equivalent |