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FDA 510(k)

SSCIMED CORONARY GUIDE WIRE/INFUSION CATHETER

K-Number: K952872 · 1995-07-27

ApplicantScimed Life Systems, Inc.
Decision Date1995-07-27
Product CodeKRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SSCIMED CORONARY GUIDE WIRE/INFUSION 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 1995-07-27 under 510(k) number K952872. 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 SSCIMED CORONARY GUIDE WIRE/INFUSION CATHETER?

SSCIMED CORONARY GUIDE WIRE/INFUSION CATHETER is a medical device that received FDA 510(k) clearance on 1995-07-27. The listed applicant is Scimed Life Systems, Inc.. The 510(k) number is K952872.

When did SSCIMED CORONARY GUIDE WIRE/INFUSION CATHETER receive FDA 510(k) clearance?

SSCIMED CORONARY GUIDE WIRE/INFUSION CATHETER received FDA 510(k) clearance on 1995-07-27, under 510(k) number K952872.

Who is the listed applicant for SSCIMED CORONARY GUIDE WIRE/INFUSION 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 SSCIMED CORONARY GUIDE WIRE/INFUSION CATHETER?

The FDA product code for SSCIMED CORONARY GUIDE WIRE/INFUSION 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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