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FDA 510(k)

MODIFICATION TO HYPERTRANSIT INFUSION CATHETER

K-Number: K070279 · 2007-03-14

ApplicantCordis Neurovascular, Inc.
Decision Date2007-03-14
Product CodeKRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO HYPERTRANSIT INFUSION CATHETER 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 2007-03-14 under 510(k) number K070279. 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 MODIFICATION TO HYPERTRANSIT INFUSION CATHETER?

MODIFICATION TO HYPERTRANSIT INFUSION CATHETER is a medical device that received FDA 510(k) clearance on 2007-03-14. The listed applicant is Cordis Neurovascular, Inc.. The 510(k) number is K070279.

When did MODIFICATION TO HYPERTRANSIT INFUSION CATHETER receive FDA 510(k) clearance?

MODIFICATION TO HYPERTRANSIT INFUSION CATHETER received FDA 510(k) clearance on 2007-03-14, under 510(k) number K070279.

Who is the listed applicant for MODIFICATION TO HYPERTRANSIT INFUSION CATHETER?

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 MODIFICATION TO HYPERTRANSIT INFUSION CATHETER?

The FDA product code for MODIFICATION TO HYPERTRANSIT INFUSION CATHETER is KRA.

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Other records listing Cordis Neurovascular, 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.

K082324TRUFILL DCS SYRINGEK080967TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE OR TRUFILL DCS SYRINGE II, ALSO KNOWN AS THE TRUFILL DCS ORBITK071962VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS AND TRUPUSH COIL PUSHER)K063254THE TRUFILL DCS DETACHABLE COIL SYSTEM; THE TRUFILL DCS ORBIT DETACHABLE COIL SYSTEMK053197TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM LINE EXTENSIONK043538HYPERTRANSIT INFUSION CATHETER

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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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