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FDA 510(k)

SAFESEPT TRANSSEPTAL TROCAR GUIDEWIRE

K-Number: K081986 · 2008-11-14

ApplicantOscor, Inc.
Decision Date2008-11-14
Product CodeDRC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SAFESEPT TRANSSEPTAL TROCAR GUIDEWIRE is the device name listed in this FDA 510(k) record. The listed applicant is Oscor, Inc.. It received FDA 510(k) clearance on 2008-11-14 under 510(k) number K081986. The device is classified under product code DRC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAFESEPT TRANSSEPTAL TROCAR GUIDEWIRE?

SAFESEPT TRANSSEPTAL TROCAR GUIDEWIRE is a medical device that received FDA 510(k) clearance on 2008-11-14. The listed applicant is Oscor, Inc.. The 510(k) number is K081986.

When did SAFESEPT TRANSSEPTAL TROCAR GUIDEWIRE receive FDA 510(k) clearance?

SAFESEPT TRANSSEPTAL TROCAR GUIDEWIRE received FDA 510(k) clearance on 2008-11-14, under 510(k) number K081986.

Who is the listed applicant for SAFESEPT TRANSSEPTAL TROCAR GUIDEWIRE?

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 SAFESEPT TRANSSEPTAL TROCAR GUIDEWIRE?

The FDA product code for SAFESEPT TRANSSEPTAL TROCAR GUIDEWIRE is DRC.

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Other records listing Oscor, Inc. as applicant

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K210627Breezeway IIK130104GUIDEWIRE, PURSUER SERIESK122958DELIVERY SHEATH, MODEL ADELANTE BREEZEWAYK122960STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINOK122084INTRODUCER SET, MODEL ADELANTE-S SERIESK120459STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO

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Related Devices (Code: DRC)

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.

K240246Accusafe Transseptal Guidewire (GTR31180, GTR31230)Synaptic Medical CorporationK241042SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)Pressure Products Medical Device Manufacturing, LLCK221707SafeSept® Transseptal Guidewire (SS-140)Pressure Products Medical Device Manufacturing, LLCK212625PathBuilder Transseptal NeedleShanghai Microport EP Medtech Co., Ltd.K210328SafeSept Blunt NeedlePressure Products Medical Device Manufacturing, LLCK172950TSN Transseptal NeedlePressure Products Medical Device Manufacturing, 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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