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FDA 510(k)

PROTECTOR INTRODUCER SHEATH

K-Number: K930808 · 1994-03-15

ApplicantBoston Scientific /International Technologies
Decision Date1994-03-15
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PROTECTOR INTRODUCER SHEATH is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific /International Technologies. It received FDA 510(k) clearance on 1994-03-15 under 510(k) number K930808. 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 PROTECTOR INTRODUCER SHEATH?

PROTECTOR INTRODUCER SHEATH is a medical device that received FDA 510(k) clearance on 1994-03-15. The listed applicant is Boston Scientific /International Technologies. The 510(k) number is K930808.

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

PROTECTOR INTRODUCER SHEATH received FDA 510(k) clearance on 1994-03-15, under 510(k) number K930808.

Who is the listed applicant for PROTECTOR INTRODUCER SHEATH?

The FDA 510(k) record lists Boston Scientific /International Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROTECTOR INTRODUCER SHEATH?

The FDA product code for PROTECTOR INTRODUCER SHEATH is DYB.

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Other records listing Boston Scientific /International Technologies 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.

K971688IVT 0.014 PTFE-COATED TRACKWIREK96366311F GUIDING CATHETERK954552RAILWIREK954622IVT 0.014 TRACK OR IVT 0.014 ACCUTRACK

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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