FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INTRAMED SIDE BRANCH OCCLUSION (SBO) SYSTEM (700095 AND 700099)
K Number: K964021
·
Decision Mar 27, 1997
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
184
Applicant Total
11
Review Days
171
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Basic Information
- Device Name
- INTRAMED SIDE BRANCH OCCLUSION (SBO) SYSTEM (700095 AND 700099)
- K Number
- K964021
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5950
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Baxter Edwards
- Date Received
- October 7, 1996
- Decision Date
- March 27, 1997
- Product Code
- HCG
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| HCG | Device, Neurovascular Embolization | FDA class 2 | Neurology |
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| K944858 | BAXTER EPTFE EXTERNALLY SUPPORTED VASCULAR GRAFTS | Jan 5, 1995 | Substantially Equivalent - Subject to Tracking Reg. |
| K940795 | SWAN-GANZ CC0/SVO2 THERMODILUTION CATHETER | May 24, 1994 | Substantially Equivalent |
| K926433 | 4.5F IMAGECATH(R) CORONARY ANGIOSCOPE, COV45 | Mar 23, 1993 | Substantially Equivalent |