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FDA 510(k)

SCIMED 8 FRENCH BIG-MAX GUIDE CATHETER

K-Number: K943777 · 1994-10-13

ApplicantScimed Life Systems, Inc.
Decision Date1994-10-13
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SCIMED 8 FRENCH BIG-MAX GUIDE CATHETER 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 1994-10-13 under 510(k) number K943777. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCIMED 8 FRENCH BIG-MAX GUIDE CATHETER?

SCIMED 8 FRENCH BIG-MAX GUIDE CATHETER is a medical device that received FDA 510(k) clearance on 1994-10-13. The listed applicant is Scimed Life Systems, Inc.. The 510(k) number is K943777.

When did SCIMED 8 FRENCH BIG-MAX GUIDE CATHETER receive FDA 510(k) clearance?

SCIMED 8 FRENCH BIG-MAX GUIDE CATHETER received FDA 510(k) clearance on 1994-10-13, under 510(k) number K943777.

Who is the listed applicant for SCIMED 8 FRENCH BIG-MAX GUIDE CATHETER?

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 8 FRENCH BIG-MAX GUIDE CATHETER?

The FDA product code for SCIMED 8 FRENCH BIG-MAX GUIDE CATHETER is DQY.

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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: DQY)

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.

K262817CrossFAST Integrated Microcatheter Advanced Delivery SystemVantis Vascular, Inc.K260559NHanceITIMDS Operation B.V.K262392APRO 35 Swift CatheterAlembic, LLCK262240SSPC NXT Delivery CatheterCenterPoint Systems, LLCK261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLCK261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterAbbott

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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