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FDA 510(k)

SCIMED DISPATCH GOLD CORONARY CATHETER

K-Number: K961294 · 1996-07-03

ApplicantScimed Life Systems, Inc.
Decision Date1996-07-03
Product CodeKRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SCIMED DISPATCH GOLD CORONARY 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 1996-07-03 under 510(k) number K961294. The device is classified under product code KRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCIMED DISPATCH GOLD CORONARY CATHETER?

SCIMED DISPATCH GOLD CORONARY CATHETER is a medical device that received FDA 510(k) clearance on 1996-07-03. The listed applicant is Scimed Life Systems, Inc.. The 510(k) number is K961294.

When did SCIMED DISPATCH GOLD CORONARY CATHETER receive FDA 510(k) clearance?

SCIMED DISPATCH GOLD CORONARY CATHETER received FDA 510(k) clearance on 1996-07-03, under 510(k) number K961294.

Who is the listed applicant for SCIMED DISPATCH GOLD CORONARY 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 DISPATCH GOLD CORONARY CATHETER?

The FDA product code for SCIMED DISPATCH GOLD CORONARY CATHETER is KRA.

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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: KRA)

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.

K253509TriSalus TriNav Advance Infusion SystemTrisalus Life SciencesK254051Extroducer Infusion Catheter SystemSmartWise Sweden ABK261610Verge™ MicrocatheterInstylla, Inc.K260771TruSelect™ 2.6 MicrocatheterBoston Scientific CorporationK250794InVera Infusion DeviceInvera MedicalK243534Micro CatheterSuzhou Zenith Vascular SciTech Limited

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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