FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VP WIRE GW140ST (.014 165CM, STANDAR), MODEL GW140ST; VP WIRE GW140SO (.014 165CM, SOFT) MODEL GW140SO
K Number: K051062
·
Decision Jul 15, 2005
Classifications
1
FEI Numbers
257
Registration Numbers
258
Same Product Code
763
Applicant Total
11
Review Days
80
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Basic Information
- Device Name
- VP WIRE GW140ST (.014 165CM, STANDAR), MODEL GW140ST; VP WIRE GW140SO (.014 165CM, SOFT) MODEL GW140SO
- K Number
- K051062
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1330
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Flowcardia, Inc.
- Date Received
- April 26, 2005
- Decision Date
- July 15, 2005
- Product Code
- DQX
- 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 |
|---|---|---|---|
| DQX | Wire, Guide, Catheter | FDA class 2 | Cardiovascular |
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Other Clearances by Flowcardia, Inc.
| K Number | Device Name | ||
|---|---|---|---|
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| K090621 | FLOWCARDIA FLOWMATER INJECTOR, MODEL INJ 100 | Jun 19, 2009 | Substantially Equivalent |
| K091254 | THE CROSSER 14 OTW CATHETER, MODEL CRU014 | May 29, 2009 | Substantially Equivalent |
| K091119 | MODIFICATION TO THE CROSSER SYSTEM | May 15, 2009 | Substantially Equivalent |
| K080849 | MICROSHEATH LP AND LP-AT | Jul 25, 2008 | Substantially Equivalent |
| K080765 | CROSSER LP SYSTEM | Jun 20, 2008 | Substantially Equivalent |
| K073289 | MICROSHEATH XL CATHETERS | Jan 11, 2008 | Substantially Equivalent |
| K072776 | THE CROSSER SYSTEM | Dec 7, 2007 | Substantially Equivalent |
| K062868 | THE CROSSER CATHETER, MODEL CR1100 AND SYSTEM ELECTRONICS, MODEL FG1002-02 | Jan 19, 2007 | Substantially Equivalent |
| K051580 | VP SHEATH | Oct 31, 2005 | Substantially Equivalent |