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FDA 510(k)

TORFLEX TRANSSEPTAL GUIDING SHEATH

K-Number: K102948 · 2011-04-01

ApplicantBaylis Medical Co., Inc.
Decision Date2011-04-01
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TORFLEX TRANSSEPTAL GUIDING SHEATH is the device name listed in this FDA 510(k) record. The listed applicant is Baylis Medical Co., Inc.. It received FDA 510(k) clearance on 2011-04-01 under 510(k) number K102948. 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 TORFLEX TRANSSEPTAL GUIDING SHEATH?

TORFLEX TRANSSEPTAL GUIDING SHEATH is a medical device that received FDA 510(k) clearance on 2011-04-01. The listed applicant is Baylis Medical Co., Inc.. The 510(k) number is K102948.

When did TORFLEX TRANSSEPTAL GUIDING SHEATH receive FDA 510(k) clearance?

TORFLEX TRANSSEPTAL GUIDING SHEATH received FDA 510(k) clearance on 2011-04-01, under 510(k) number K102948.

Who is the listed applicant for TORFLEX TRANSSEPTAL GUIDING SHEATH?

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

What is the FDA product code for TORFLEX TRANSSEPTAL GUIDING SHEATH?

The FDA product code for TORFLEX TRANSSEPTAL GUIDING SHEATH is DYB.

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Other records listing Baylis Medical Co., 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.

K122926SUREFLEX STEERABLE GUIDING SHEATH KITK111523OSTEOCOOL (TM) RF ABLATION SYSTEMK102192INDISCAL DIGITAL MANOMETERK101372DUOCOOL PAIN MANAGEMENT PROBE, MODEL OSP-17-180-20K101615POWERWIRE RADIOFREQUENCY GUIDEWIREK101117LEV-OR DILATION CATHETER OTW

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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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