FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THE CROSSER SYSTEM
K Number: K072776
·
Decision Dec 7, 2007
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
56
Applicant Total
11
Review Days
70
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Basic Information
- Device Name
- THE CROSSER SYSTEM
- K Number
- K072776
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Flowcardia, Inc.
- Date Received
- September 28, 2007
- Decision Date
- December 7, 2007
- Product Code
- PDU
- 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 |
|---|---|---|---|
| PDU | Catheter For Crossing Total Occlusions | FDA class 2 | Cardiovascular |
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Other Clearances by Flowcardia, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K092175 | THE CROSSER S6 CATHETER, THE CROSSER SYSTEM ELECTRONICS, MODEL CRUS6, GEN200 | Feb 17, 2010 | Substantially Equivalent |
| 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 |
| 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 |
| K051062 | VP WIRE GW140ST (.014 165CM, STANDAR), MODEL GW140ST; VP WIRE GW140SO (.014 165CM, SOFT) MODEL GW140SO | Jul 15, 2005 | Substantially Equivalent |