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FDA 510(k)

DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY

K-Number: K122958 · 2012-12-13

ApplicantOscor, Inc.
Decision Date2012-12-13
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY is the device name listed in this FDA 510(k) record. The listed applicant is Oscor, Inc.. It received FDA 510(k) clearance on 2012-12-13 under 510(k) number K122958. 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 DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY?

DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY is a medical device that received FDA 510(k) clearance on 2012-12-13. The listed applicant is Oscor, Inc.. The 510(k) number is K122958.

When did DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY receive FDA 510(k) clearance?

DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY received FDA 510(k) clearance on 2012-12-13, under 510(k) number K122958.

Who is the listed applicant for DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY?

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

What is the FDA product code for DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY?

The FDA product code for DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY is DYB.

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Other records listing Oscor, 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.

K210627Breezeway IIK130104GUIDEWIRE, PURSUER SERIESK122960STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINOK122084INTRODUCER SET, MODEL ADELANTE-S SERIESK120459STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINOK101497DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY

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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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