INDEFLATOR 20/30 INFLATION DEVICE AND 20/30 PRIORITY PACK (WITH THE .096 OR .115 ROTATING HEMOSTATIC VALVE)— 510(k) K961471
UnknownAdvanced Cardiovascular Systems, Inc.
FDA 510(k) clearance K961471 for INDEFLATOR 20/30 INFLATION DEVICE AND 20/30 PRIORITY PACK (WITH THE .096 OR .115 ROTATING HEMOSTATIC VALVE), Unknown on 1996-05-08. Applicant: Advanced Cardiovascular Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Advanced Cardiovascular Systems, Inc.
- Product code
- Code MAV
- Device class
- Class 2
- Regulation
- 21 CFR 870.1650
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Traditional
- Location
- Santa Clara, CA, US
Recent devices under product code MAV
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- K162272 — Fluent inflation device
- K153038 — Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival Kit
- K153672 — basixTOUCH40 Inflation Syringe
More clearances from Advanced Cardiovascular Systems, Inc.
view all- K012534 — HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
- K000550 — OTW MEGALINK SDS BILIARY STENT SYSTEM
- K994229 — VERIPATH PERIPHERAL GUIDING CATHETER
- K992169 — ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE
- K990867 — RX HERCULINK 14 BILIARY STENT SYSTEM, MODEL 1005126-18,1005128-18,1005130-18,1005132-18,1005134-18,1005136-18,1005138-18
Adverse events under product code MAV
product code MAV- Malfunction
- 1,433
- Total
- 1,433
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K961471
K-number listed on FDA's recall record- Z-0730-2025 — 20/30 INDEFLATOR, REF: 1000184, for use during cardiovascular procedures in conjunction with interventional devices such as balloon dilatation catheters to create and monitor pressure in the balloon.
- Z-0731-2025 — 20/30 Priority Pack Accessory Kit/.096 RHV, REF: 1000186, or use during vascular procedures in conjunction with interventional and / or diagnostic devices (e.g., balloon dilatation catheters, atherectomy devices, stent delivery systems, intravascular ultrasound devices).
- Z-0732-2025 — 20/30 Priority Pack Accessory Kit w/Copilot, REF: 1003327, used for cardiovascular procedures.
- Z-0733-2025 — 20/30 Priority Pack Kit/.115 RHV, REF: 1000186-115, used for cardiovascular procedures.
- Z-0921-2022 — 20/30 INDEFLATOR -REF 1000184 WPL2122268-01 (2019-03-01)
- Z-0922-2022 — 20/30 Priority Pack Accessory Kit/.096 RHV - REF 1000186 WPL2122270-01 (2019-03-01) 20/30 Priority Pack w/.115 RHV - REF 1000186-115 WPL2122270-02 (2019-03-01)
- Z-0923-2022 — 20/30 Priority Pack w/COPILOT - REF 1003327 WPL2122272-01 (2019-03-01)
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K961471.
Data sourced from openFDA. This site is unofficial and independent of the FDA.