FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CATALYST II AND III
K Number: K130124
·
Decision Mar 14, 2013
Classifications
1
FEI Numbers
186
Registration Numbers
186
Same Product Code
203
Applicant Total
7
Review Days
56
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Basic Information
- Device Name
- CATALYST II AND III
- K Number
- K130124
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4450
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cardiva Medical, Inc.
- Date Received
- January 17, 2013
- Decision Date
- March 14, 2013
- Product Code
- DXC
- 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 |
|---|---|---|---|
| DXC | Clamp, Vascular | FDA class 2 | Cardiovascular |
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Other Clearances by Cardiva Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K082930 | CARDIVA CATALYST III SYSTEM WITH PROTAMINE SULFATE | Feb 13, 2009 | Substantially Equivalent |
| K072297 | BOOMERANG CATALYST/BOOMERANG CATALYST II SYSTEM | Sep 12, 2007 | Substantially Equivalent |
| K070485 | BOOMERANG WIRE /BOOMERANG PLUS WIRE SYSTEM, MODEL# B PLUS WIRE 58L | Mar 22, 2007 | Substantially Equivalent |
| K051817 | BOOMERANG CLOSUREWIRE VASCULAR CLOSURE SYSTEM | Dec 6, 2006 | Substantially Equivalent |
| K061075 | BOOMERANG WIRE | Sep 1, 2006 | Substantially Equivalent |
| K041486 | VASOSTASIS VASCULAR CLOSURE SYSTEM | Oct 22, 2004 | Substantially Equivalent |