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FDA 510(k)

70 NeuGlide Catheter

K-Number: K262277 · 2026-09-04

ApplicantPiraeus Medical, Inc.
Decision Date2026-09-04
Product CodeQJP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

70 NeuGlide Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Piraeus Medical, Inc.. It received FDA 510(k) clearance on 2026-09-04 under 510(k) number K262277. The device is classified under product code QJP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 70 NeuGlide Catheter?

70 NeuGlide Catheter is a medical device that received FDA 510(k) clearance on 2026-09-04. The listed applicant is Piraeus Medical, Inc.. The 510(k) number is K262277.

When did 70 NeuGlide Catheter receive FDA 510(k) clearance?

70 NeuGlide Catheter received FDA 510(k) clearance on 2026-09-04, under 510(k) number K262277.

Who is the listed applicant for 70 NeuGlide Catheter?

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

What is the FDA product code for 70 NeuGlide Catheter?

The FDA product code for 70 NeuGlide Catheter is QJP.

Other records listing Piraeus Medical, 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.

K26075135 Helix GuidewireK25104493 NeuFlex CatheterK24097187 NeuGlide Catheter

Related Devices (Code: QJP)

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.

K261176Zoom 4S CatheterImperative Care, Inc.K254071p17 XR MicrocatheterWallaby MedicalK260199SLIM MicrocatheterBalt USA, LLCK253901Millipede88 Access CatheterPerfuze, Ltd.K261889Trevo Trak 21 MicrocatheterStryker NeurovascularK261808ISAAC Neurovascular Navigation CatheterMicrovention Inc. d/b/a Terumo Neuro

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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