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FDA 510(k)

LARIAT II SUTURE DELIVERY DEVICE

K-Number: K090385 · 2009-05-06

ApplicantSentreheart, Inc.
Decision Date2009-05-06
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LARIAT II SUTURE DELIVERY DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Sentreheart, Inc.. It received FDA 510(k) clearance on 2009-05-06 under 510(k) number K090385. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LARIAT II SUTURE DELIVERY DEVICE?

LARIAT II SUTURE DELIVERY DEVICE is a medical device that received FDA 510(k) clearance on 2009-05-06. The listed applicant is Sentreheart, Inc.. The 510(k) number is K090385.

When did LARIAT II SUTURE DELIVERY DEVICE receive FDA 510(k) clearance?

LARIAT II SUTURE DELIVERY DEVICE received FDA 510(k) clearance on 2009-05-06, under 510(k) number K090385.

Who is the listed applicant for LARIAT II SUTURE DELIVERY DEVICE?

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

What is the FDA product code for LARIAT II SUTURE DELIVERY DEVICE?

The FDA product code for LARIAT II SUTURE DELIVERY DEVICE is GAT.

Related Clinical Trials

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Other records listing Sentreheart, 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.

K080364FINDRWIRZ GUIDE WIRE SYSTEMK070126OCCLUSION BALLOON CATHETER

Related Devices (Code: GAT)

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.

K253910Stitch - Suture Wires and TapesGM Dos Reis Industria e Comercio Ltda.K261021EasyWhip FamilyWinter Innovations, Inc.K260775Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™Teleflex Medical, LLCK254275HyperSuture All Green Extension LineThreadstone, LLCK254188Meniscus VersaflexGM Dos Reis Industria e Comercio Ltda.K253145Pre-Sutured TendonRti Surgical, Inc.

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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