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FDA 510(k)

TRANSIT INFUSION CATHETER WITH SIDEHOLES

K-Number: K954949 · 1995-12-22

ApplicantCordis Neurovascular, Inc.
Decision Date1995-12-22
Product CodeKRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TRANSIT INFUSION CATHETER WITH SIDEHOLES is the device name listed in this FDA 510(k) record. The listed applicant is Cordis Neurovascular, Inc.. It received FDA 510(k) clearance on 1995-12-22 under 510(k) number K954949. 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 TRANSIT INFUSION CATHETER WITH SIDEHOLES?

TRANSIT INFUSION CATHETER WITH SIDEHOLES is a medical device that received FDA 510(k) clearance on 1995-12-22. The listed applicant is Cordis Neurovascular, Inc.. The 510(k) number is K954949.

When did TRANSIT INFUSION CATHETER WITH SIDEHOLES receive FDA 510(k) clearance?

TRANSIT INFUSION CATHETER WITH SIDEHOLES received FDA 510(k) clearance on 1995-12-22, under 510(k) number K954949.

Who is the listed applicant for TRANSIT INFUSION CATHETER WITH SIDEHOLES?

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

What is the FDA product code for TRANSIT INFUSION CATHETER WITH SIDEHOLES?

The FDA product code for TRANSIT INFUSION CATHETER WITH SIDEHOLES is KRA.

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Other records listing Cordis Neurovascular, Inc. as applicant

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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