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FDA 510(k)

SCIMED ENCORE 26 INFLATION DEVICE/ENCORE 30 INFLATION DEVICE

K-Number: K955869 · 1996-03-22

ApplicantScimed Life Systems, Inc.
Decision Date1996-03-22
Product CodeMAV
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SCIMED ENCORE 26 INFLATION DEVICE/ENCORE 30 INFLATION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Scimed Life Systems, Inc.. It received FDA 510(k) clearance on 1996-03-22 under 510(k) number K955869. The device is classified under product code MAV. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCIMED ENCORE 26 INFLATION DEVICE/ENCORE 30 INFLATION DEVICE?

SCIMED ENCORE 26 INFLATION DEVICE/ENCORE 30 INFLATION DEVICE is a medical device that received FDA 510(k) clearance on 1996-03-22. The listed applicant is Scimed Life Systems, Inc.. The 510(k) number is K955869.

When did SCIMED ENCORE 26 INFLATION DEVICE/ENCORE 30 INFLATION DEVICE receive FDA 510(k) clearance?

SCIMED ENCORE 26 INFLATION DEVICE/ENCORE 30 INFLATION DEVICE received FDA 510(k) clearance on 1996-03-22, under 510(k) number K955869.

Who is the listed applicant for SCIMED ENCORE 26 INFLATION DEVICE/ENCORE 30 INFLATION DEVICE?

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

What is the FDA product code for SCIMED ENCORE 26 INFLATION DEVICE/ENCORE 30 INFLATION DEVICE?

The FDA product code for SCIMED ENCORE 26 INFLATION DEVICE/ENCORE 30 INFLATION DEVICE is MAV.

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Other records listing Scimed Life 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.

K974241SCIMED INFORMER PRESSURE WIRE SYSTEMK981788SCIMED 6 FRENCH WISEGUIDE GUIDE CATHETERK980360SCIMED QUEST FLOPPY AND MODERATE SUPPORT GUIDE WIRESK974559SCIMED 6 FRENCH IMPULSE ANGIOGRAPHIC CATHETERSK974684SCIMED 7 FRENCH WISEGUIDE GUIDE CATHETERK973945LUGE 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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