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FDA 510(k)

SPREADABLE SHEATH INTRODUCER SET

K-Number: K960625 · 1996-08-08

ApplicantNeostar Medical Technologies, Inc.
Decision Date1996-08-08
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SPREADABLE SHEATH INTRODUCER SET is the device name listed in this FDA 510(k) record. The listed applicant is Neostar Medical Technologies, Inc.. It received FDA 510(k) clearance on 1996-08-08 under 510(k) number K960625. 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 SPREADABLE SHEATH INTRODUCER SET?

SPREADABLE SHEATH INTRODUCER SET is a medical device that received FDA 510(k) clearance on 1996-08-08. The listed applicant is Neostar Medical Technologies, Inc.. The 510(k) number is K960625.

When did SPREADABLE SHEATH INTRODUCER SET receive FDA 510(k) clearance?

SPREADABLE SHEATH INTRODUCER SET received FDA 510(k) clearance on 1996-08-08, under 510(k) number K960625.

Who is the listed applicant for SPREADABLE SHEATH INTRODUCER SET?

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

What is the FDA product code for SPREADABLE SHEATH INTRODUCER SET?

The FDA product code for SPREADABLE SHEATH INTRODUCER SET is DYB.

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Other records listing Neostar Medical Technologies, 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.

K944511ACUTE CENTRAL VENOUS ACCESS CATHETER (ACVAC)K944660ACUTE CENTRAL VENOUS ACCESS CATHETER TRAYK941851DUAL LUMEN CATHETER (DLC) TRAY

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

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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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