FDA 510(k)

SELECTIVE INFUSION II CATHETER

K-Number: K914751 · 1993-05-24

ApplicantAdvanced Cardiovascular Systems, Inc.

Decision Date1993-05-24

Product CodeKRA

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

SELECTIVE INFUSION II CATHETER 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 1993-05-24 under 510(k) number K914751. 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 SELECTIVE INFUSION II CATHETER?

SELECTIVE INFUSION II CATHETER is a medical device that received FDA 510(k) clearance on 1993-05-24. The listed applicant is Advanced Cardiovascular Systems, Inc.. The 510(k) number is K914751.

When did SELECTIVE INFUSION II CATHETER receive FDA 510(k) clearance?

SELECTIVE INFUSION II CATHETER received FDA 510(k) clearance on 1993-05-24, under 510(k) number K914751.

Who is the listed applicant for SELECTIVE INFUSION II CATHETER?

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 SELECTIVE INFUSION II CATHETER?

The FDA product code for SELECTIVE INFUSION II CATHETER is KRA.

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Other records listing Advanced Cardiovascular Systems, Inc. as applicant

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Related Devices (Code: KRA)

K253509TriSalus TriNav Advance Infusion SystemTrisalus Life Sciences K254051Extroducer Infusion Catheter SystemSmartWise Sweden AB K261610Verge™ MicrocatheterInstylla, Inc.K260771TruSelect™ 2.6 MicrocatheterBoston Scientific Corporation K250794InVera Infusion DeviceInvera Medical K243534Micro 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.