FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GUIDE WIRE
K Number: K821190
·
Decision Aug 31, 1982
Classifications
1
FEI Numbers
252
Registration Numbers
253
Same Product Code
751
Applicant Total
103
Review Days
126
Basic Information
- Device Name
- GUIDE WIRE
- K Number
- K821190
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1330
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- ADVANCED CARDIOVASCULAR SYSTEMS, INC.
- Date Received
- April 27, 1982
- Decision Date
- August 31, 1982
- Product Code
- DQX
- 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 |
|---|---|---|---|
| DQX | Wire, Guide, Catheter | FDA class 2 | Cardiovascular |
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| K Number | Device Name | ||
|---|---|---|---|
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| 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 |