FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ESTECH EASYFLOW CANNULA WITH GUIDEWIRE
K Number: K091542
·
Decision Oct 20, 2009
Classifications
1
FEI Numbers
104
Registration Numbers
104
Same Product Code
400
Applicant Total
5
Review Days
147
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Basic Information
- Device Name
- ESTECH EASYFLOW CANNULA WITH GUIDEWIRE
- K Number
- K091542
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4210
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Endoscopic Technologies, Inc. D/B/A Estech
- Date Received
- May 26, 2009
- Decision Date
- October 20, 2009
- Product Code
- DWF
- 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 |
|---|---|---|---|
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
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Other Clearances by Endoscopic Technologies, Inc. D/B/A Estech
| K Number | Device Name | ||
|---|---|---|---|
| K113475 | ESTECH COBRA ADHERE XL 2 SURGICAL SYSTEM | Mar 20, 2012 | Substantially Equivalent |
| K110913 | ESTECH COBRA SURGICAL SYSTEM WITH THERMASHIELD ACCESSORY | Sep 23, 2011 | Substantially Equivalent |
| K100224 | ESTECH COBRA BIPOLSR II | Apr 7, 2010 | Substantially Equivalent |
| K091350 | ESTECH HAWKEYE INTRODUCER SYSTEMS | Sep 15, 2009 | Substantially Equivalent |