FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SMASH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CARDIOVASCULAR DEVICES PANEL
K Number: K972512
·
Decision Feb 12, 1998
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
402
Applicant Total
35
Review Days
220
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Basic Information
- Device Name
- SMASH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CARDIOVASCULAR DEVICES PANEL
- K Number
- K972512
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Boston Scientific Scimed, Inc.
- Date Received
- July 7, 1997
- Decision Date
- February 12, 1998
- Product Code
- LIT
- 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 |
|---|---|---|---|
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | FDA class 2 | Cardiovascular |
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Other Clearances by Boston Scientific Scimed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K041727 | MODIFICATION TO ATLANTIS PV IMAGING CATHETER, MODEL 36456 | Jul 23, 2004 | Substantially Equivalent |
| K030617 | PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIRE | May 21, 2003 | Substantially Equivalent |
| K024048 | MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM | Jan 6, 2003 | Unknown |
| K021735 | BOSTON SCIENTIFIC ULTRA-SOFT SV BALLOON DILATATION CATHETER | Aug 8, 2002 | Substantially Equivalent |
| K021901 | WALLGRAFT TRACHEOBRONCHIAL ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM | Jul 9, 2002 | Substantially Equivalent |
| K012822 | MODIFICIATION TO: BILIARY WALLSTENT ENDOPROSTHEIS WITH MONORAIL DELIVERY SYSTEM, MODEL 71-XXX | Oct 24, 2001 | Unknown |
| K012216 | NIROYAL BILIARY PREMOUNTED STENT SYSTEM | Aug 17, 2001 | Unknown |
| K000743 | BOSTON SCIENTIFIC SCIMED ATLANTIS CORONARY IMAGING CATHETER, MODEL C4020 | Sep 6, 2000 | Substantially Equivalent |
| K000001 | WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM | Jun 5, 2000 | Substantially Equivalent |
| K000956 | MODIFICATION TO SCIMED 6F IMPULSE ANGIOGRAPHIC CATHATERS | Apr 21, 2000 | Substantially Equivalent |