FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPECTRANETICS QUICK-CROSS SUPPORT2 CATHETERS, MODELS 518-065 AND 518-066
K Number: K072750
·
Decision Dec 4, 2007
Classifications
1
FEI Numbers
276
Registration Numbers
277
Same Product Code
889
Applicant Total
24
Review Days
68
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Basic Information
- Device Name
- SPECTRANETICS QUICK-CROSS SUPPORT2 CATHETERS, MODELS 518-065 AND 518-066
- K Number
- K072750
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Spectranetics Corp.
- Date Received
- September 27, 2007
- Decision Date
- December 4, 2007
- Product Code
- DQY
- 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 |
|---|---|---|---|
| DQY | Catheter, Percutaneous | FDA class 2 | Cardiovascular |
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| K092378 | SPECTRANETICS VISISHEATH DILATOR SHEATH | Nov 2, 2009 | Substantially Equivalent |
| K092396 | SPECTRANETICS QUICK CROSS EXTREME SUPPORT CATHETERS | Sep 4, 2009 | Substantially Equivalent |
| K091299 | SPECTRANETICS TURBO-TANDEM SYSTEM | Jul 1, 2009 | Substantially Equivalent |
| K090913 | CROSS-PILOT TURBO ELITE SUPPORT CATHETER | May 4, 2009 | Substantially Equivalent |
| K082559 | SPECTRANETICS CROSS-PILOT TURBO ELITE SUPPORT CATHETER | Dec 11, 2008 | Substantially Equivalent |