FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SCIMED IMPULSE ANGIOGRAPHIC CATHETERS
K Number: K992123
·
Decision Aug 23, 1999
Classifications
1
FEI Numbers
210
Registration Numbers
211
Same Product Code
499
Applicant Total
35
Review Days
61
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Basic Information
- Device Name
- SCIMED IMPULSE ANGIOGRAPHIC CATHETERS
- K Number
- K992123
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1200
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Boston Scientific Scimed, Inc.
- Date Received
- June 23, 1999
- Decision Date
- August 23, 1999
- Product Code
- DQO
- 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 |
|---|---|---|---|
| DQO | Catheter, Intravascular, Diagnostic | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DQO), ordered by most recent decision date.
Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602N
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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 |
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| 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 |