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FDA 510(k)

OPTISEAL ENPATH VALVED PTFE PEELABLE INTRODUCER

K-Number: K093232 · 2010-03-15

ApplicantGreat Batch Medical
Decision Date2010-03-15
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OPTISEAL ENPATH VALVED PTFE PEELABLE INTRODUCER is the device name listed in this FDA 510(k) record. The listed applicant is Great Batch Medical. It received FDA 510(k) clearance on 2010-03-15 under 510(k) number K093232. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTISEAL ENPATH VALVED PTFE PEELABLE INTRODUCER?

OPTISEAL ENPATH VALVED PTFE PEELABLE INTRODUCER is a medical device that received FDA 510(k) clearance on 2010-03-15. The listed applicant is Great Batch Medical. The 510(k) number is K093232.

When did OPTISEAL ENPATH VALVED PTFE PEELABLE INTRODUCER receive FDA 510(k) clearance?

OPTISEAL ENPATH VALVED PTFE PEELABLE INTRODUCER received FDA 510(k) clearance on 2010-03-15, under 510(k) number K093232.

Who is the listed applicant for OPTISEAL ENPATH VALVED PTFE PEELABLE INTRODUCER?

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

What is the FDA product code for OPTISEAL ENPATH VALVED PTFE PEELABLE INTRODUCER?

The FDA product code for OPTISEAL ENPATH VALVED PTFE PEELABLE INTRODUCER is DYB.

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Other records listing Great Batch Medical 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.

K181855RadialSeal Introducer KitK130559MOBICATH BI-DIRECTIONAL GUIDING SHEATHK122832MOBICATH TRANSSEPTAL NEEDLEK112541Z FLEX-270TM STEERABLE SHEATHK110051RADIALSOURCE TRANSRADIAL ACCESS INTRODUCER KITK111644MOBICATH TRANSSEPTAL NEEDLE

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Related Devices (Code: DYB)

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.

K253526NAMIC Dilator and SheathMedline Industries, LPK261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04)Hartman Medical Group, LLCK261242SimplGuidePendracareK261950Health Line Tearaway IntroducerHealth Line International CorporationK261492FieldFlex Steerable SheathCenterPoint Systems, LLCK260606Echo Large Bore Introducer SheathEcho Medical, LLC

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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