FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACS SELECTIVE INFUSION CATHETER
K Number: K885237
·
Decision Mar 16, 1989
Classifications
1
FEI Numbers
276
Registration Numbers
277
Same Product Code
889
Applicant Total
103
Review Days
85
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Basic Information
- Device Name
- ACS SELECTIVE INFUSION CATHETER
- K Number
- K885237
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Advanced Cardiovascular Systems, Inc.
- Date Received
- December 21, 1988
- Decision Date
- March 16, 1989
- 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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Other Clearances by Advanced Cardiovascular Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K012534 | HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING | Jan 24, 2002 | Substantially Equivalent |
| K000550 | OTW MEGALINK SDS BILIARY STENT SYSTEM | Mar 17, 2000 | Unknown |
| K994229 | VERIPATH PERIPHERAL GUIDING CATHETER | Feb 25, 2000 | Substantially Equivalent |
| K992169 | ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE | Oct 28, 1999 | Substantially Equivalent |
| K990867 | RX HERCULINK 14 BILIARY STENT SYSTEM, MODEL 1005126-18,1005128-18,1005130-18,1005132-18,1005134-18,1005136-18,1005138-18 | Sep 2, 1999 | Unknown |
| K963702 | ACS HI-TORQUE IRON MAN GUIDE WIRE | Jan 22, 1997 | Substantially Equivalent |
| K962495 | INDEFLATOR PLUS 30/PLUS 30 PRIORITY PACK9WITH THE.096 OR.115 ROTATING HEMOSTATIC VALVE) | Sep 12, 1996 | Substantially Equivalent |
| K961471 | INDEFLATOR 20/30 INFLATION DEVICE AND 20/30 PRIORITY PACK (WITH THE .096 OR .115 ROTATING HEMOSTATIC VALVE) | May 8, 1996 | Unknown |
| K955175 | ACS ANCHOR EXCHANGE DEVICE | Apr 5, 1996 | Substantially Equivalent |
| K953987 | ACS TOURGIDE GUIDING CATHETER | Dec 7, 1995 | Substantially Equivalent |