FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
2.5MM TURBO ELITE 035, 2.3MM TURBO ELITE 035
K Number: K123632
·
Decision Jan 25, 2013
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
145
Applicant Total
24
Review Days
63
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Basic Information
- Device Name
- 2.5MM TURBO ELITE 035, 2.3MM TURBO ELITE 035
- K Number
- K123632
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4875
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Spectranetics Corp.
- Date Received
- November 23, 2012
- Decision Date
- January 25, 2013
- Product Code
- MCW
- 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 |
|---|---|---|---|
| MCW | Catheter, Peripheral, Atherectomy | FDA class 2 | Cardiovascular |
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Other Clearances by Spectranetics Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K140047 | LEXICONTURE MECHANICAL DILATOR SHEATH SET | Apr 9, 2014 | Substantially Equivalent |
| K112032 | 8FR TURBO - TANDEM SYSTEM | Oct 17, 2011 | Substantially Equivalent |
| K093257 | TORQMAX SHEATH GRIP ACCESSORY | Mar 26, 2010 | Substantially Equivalent |
| K094036 | TURBO-TANDEM SYSTEM MODEL 472-110 | Jan 25, 2010 | Substantially Equivalent |
| 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 |
| K082561 | SPECTRANETICS QUICK-CROSS EXTREME SUPPORT CATHETERS | Dec 10, 2008 | Substantially Equivalent |