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FDA 510(k)

INDEFLATOR 20/30 INFLATION DEVICE AND 20/30 PRIORITY PACK (WITH THE .096 OR .115 ROTATING HEMOSTATIC VALVE)

K-Number: K961471 · 1996-05-08

ApplicantAdvanced Cardiovascular Systems, Inc.
Decision Date1996-05-08
Product CodeMAV
Advisory CommitteeCV
DecisionUnknown

Device Summary

INDEFLATOR 20/30 INFLATION DEVICE AND 20/30 PRIORITY PACK (WITH THE .096 OR .115 ROTATING HEMOSTATIC VALVE) is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Cardiovascular Systems, Inc.. It received FDA 510(k) clearance on 1996-05-08 under 510(k) number K961471. The device is classified under product code MAV. It was reviewed by the CV advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the INDEFLATOR 20/30 INFLATION DEVICE AND 20/30 PRIORITY PACK (WITH THE .096 OR .115 ROTATING HEMOSTATIC VALVE)?

INDEFLATOR 20/30 INFLATION DEVICE AND 20/30 PRIORITY PACK (WITH THE .096 OR .115 ROTATING HEMOSTATIC VALVE) is a medical device that received FDA 510(k) clearance on 1996-05-08. The listed applicant is Advanced Cardiovascular Systems, Inc.. The 510(k) number is K961471.

When did INDEFLATOR 20/30 INFLATION DEVICE AND 20/30 PRIORITY PACK (WITH THE .096 OR .115 ROTATING HEMOSTATIC VALVE) receive FDA 510(k) clearance?

INDEFLATOR 20/30 INFLATION DEVICE AND 20/30 PRIORITY PACK (WITH THE .096 OR .115 ROTATING HEMOSTATIC VALVE) received FDA 510(k) clearance on 1996-05-08, under 510(k) number K961471.

Who is the listed applicant for INDEFLATOR 20/30 INFLATION DEVICE AND 20/30 PRIORITY PACK (WITH THE .096 OR .115 ROTATING HEMOSTATIC VALVE)?

The FDA 510(k) record lists Advanced Cardiovascular Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INDEFLATOR 20/30 INFLATION DEVICE AND 20/30 PRIORITY PACK (WITH THE .096 OR .115 ROTATING HEMOSTATIC VALVE)?

The FDA product code for INDEFLATOR 20/30 INFLATION DEVICE AND 20/30 PRIORITY PACK (WITH THE .096 OR .115 ROTATING HEMOSTATIC VALVE) is MAV.

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Other records listing Advanced Cardiovascular Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K012534HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATINGK000550OTW MEGALINK SDS BILIARY STENT SYSTEMK994229VERIPATH PERIPHERAL GUIDING CATHETERK992169ACS HI-TORQUE CROSS-IT 400XT GUIDE WIREK990867RX HERCULINK 14 BILIARY STENT SYSTEM, MODEL 1005126-18,1005128-18,1005130-18,1005132-18,1005134-18,1005136-18,1005138-18K963702ACS HI-TORQUE IRON MAN GUIDE WIRE

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Related Devices (Code: MAV)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260035Digital Indeflator INFLANTEUAB TelemedicinaK220773Everest 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)Medtronic VascularK162272Fluent inflation deviceVascular Solutions, Inc.K153038Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival KitMedtronic, Inc.K153672basixTOUCH40 Inflation SyringeMerit Medical Systems, Inc.K130566BASIXTOUCHMerit Medical Systems, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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