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FDA 510(k)

Bendit2.7 Steerable Microcatheter

K-Number: K190126 · 2019-08-22

ApplicantBend IT Technologies, Ltd.
Decision Date2019-08-22
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Bendit2.7 Steerable Microcatheter is the device name listed in this FDA 510(k) record. The listed applicant is Bend IT Technologies, Ltd.. It received FDA 510(k) clearance on 2019-08-22 under 510(k) number K190126. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bendit2.7 Steerable Microcatheter?

Bendit2.7 Steerable Microcatheter is a medical device that received FDA 510(k) clearance on 2019-08-22. The listed applicant is Bend IT Technologies, Ltd.. The 510(k) number is K190126.

When did Bendit2.7 Steerable Microcatheter receive FDA 510(k) clearance?

Bendit2.7 Steerable Microcatheter received FDA 510(k) clearance on 2019-08-22, under 510(k) number K190126.

Who is the listed applicant for Bendit2.7 Steerable Microcatheter?

The FDA 510(k) record lists Bend IT Technologies, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bendit2.7 Steerable Microcatheter?

The FDA product code for Bendit2.7 Steerable Microcatheter is DQO.

Other records listing Bend IT Technologies, Ltd. 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.

K252213Bendit17 MicrocatheterK203842Bendit21 MicrocatheterK200582Bendit2.7 Steerable Microcatheter

Related Devices (Code: DQO)

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.

K261455Arterial Pressure Monitoring Set/TraySpectrum VascularK252702Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602NBioptimal International Pte. , Ltd.K254278Arterial Pressure Monitoring Set/TraySpectrum VascularK250751DualView CatheterTerumo CorporationK242966Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterGentuity, LLCK242420pNOVUS 21 MicrocatheterPhenox, Ltd.

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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