FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INDEFLATOR PLUS 30/PLUS 30 PRIORITY PACK9WITH THE.096 OR.115 ROTATING HEMOSTATIC VALVE)
K Number: K962495
·
Decision Sep 12, 1996
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
56
Applicant Total
103
Review Days
78
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Basic Information
- Device Name
- INDEFLATOR PLUS 30/PLUS 30 PRIORITY PACK9WITH THE.096 OR.115 ROTATING HEMOSTATIC VALVE)
- K Number
- K962495
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1650
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Advanced Cardiovascular Systems, Inc.
- Date Received
- June 26, 1996
- Decision Date
- September 12, 1996
- Product Code
- MAV
- 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 |
|---|---|---|---|
| MAV | Syringe, Balloon Inflation | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MAV), ordered by most recent decision date.
Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation Device and 3-way Stopcock (AC3200);Everest 20 Survival Kit containing:1. Everest 20 Device with 3-way Stopcock, 2. Piton Y-Adaptor ,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC2205P); Everest 30 Survival Kit containing:1. Everest 30 Device with 3-way Stopcock, 2. Piton Y-Adaptor,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC3205P)
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basixTOUCH40 Inflation Syringe
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Fluent Inflation Device
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MASTRO PLUS BALLOON IN-DEFLATION DEVICE
FDA 510(k)
FDA Class 2
·Cardiovascular
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 |
| 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 |
| K952205 | ACS POWERBASE GUILDING CATHETER | Aug 4, 1995 | Substantially Equivalent |