FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Quick-Cross Extreme Support Catheter, Quick-Cross Select Support Catheter
K Number: K150201
·
Decision Feb 27, 2015
Classifications
1
FEI Numbers
276
Registration Numbers
277
Same Product Code
889
Applicant Total
17
Review Days
29
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Basic Information
- Device Name
- Quick-Cross Extreme Support Catheter, Quick-Cross Select Support Catheter
- K Number
- K150201
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Spectranetics, Inc.
- Date Received
- January 29, 2015
- Decision Date
- February 27, 2015
- 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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| K180694 | Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters | Apr 5, 2018 | Substantially Equivalent |
| K172687 | Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters | Nov 27, 2017 | Substantially Equivalent |
| K170059 | Spectranetics Turbo-Elite Laser Atherectomy Catheters | Apr 7, 2017 | Substantially Equivalent |
| K162561 | Turbo-Power (2.0mm) Laser Atherectomy Catheters | Jan 5, 2017 | Substantially Equivalent |
| K161333 | TightRail Sub-C Rotating Dilator Sheath | Jul 8, 2016 | Substantially Equivalent |