TORFLEX TRANSSEPTAL GUIDING SHEATH— 510(k) K102948

Clearance details

Applicant

Baylis Medical Co., Inc.

Product code

Code DYB

Device class

Class 2

Regulation

21 CFR 870.1340

Advisory panel

Cardiovascular

Date received

2010-10-05

Decision date

2011-04-01

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Mississauga, Ontario, CA

• K253526 — NAMIC Dilator and Sheath2026-07-29
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• K261242 — SimplGuide2026-06-25
• K261950 — Health Line Tearaway Introducer2026-06-22
• K261492 — FieldFlex Steerable Sheath2026-06-05

• K122926 — SUREFLEX STEERABLE GUIDING SHEATH KIT2013-01-24
• K111523 — OSTEOCOOL (TM) RF ABLATION SYSTEM2012-03-13
• K102192 — INDISCAL DIGITAL MANOMETER2011-02-23
• K101372 — DUOCOOL PAIN MANAGEMENT PROBE, MODEL OSP-17-180-202010-08-10
• K101615 — POWERWIRE RADIOFREQUENCY GUIDEWIRE2010-07-28

Death

808

Injury

5,922

Malfunction

16,516

Other

5

Total

23,251

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-2069-2020 — TorFlex Transseptal Guiding Sheath ; Model numbers: TF8-32-63-45, TF8-32-63-55, TF8-32-63-90, TF8-32-63-135, TF85-32-63-37, TF85-32-63-45, TF85-32-63-55, TF85-32-63-90, TF85-32-63-135, TF8-32-81-45, TF8-32-81-55, TF8-32-81-90, TF85-32-81-37, TF85-32-81-45, TF85-32-81-55, and TF85-32-81-90.Class II·Terminated·Baylis Medical Company Inc.·20191007
• Z-2070-2020 — NRG RF Transseptal Kit; Model No.s : NTK-710-8545, NTK-710-8555, NTK-711-8545, NTK-711-8555, NTK-711-8590, NTK-P711-8545, NTK-P711-8555, NTK-710-8545S, NTK-710-8555S, NTK-711-8545S, NTK-711-8555S, NTK-710-8545N, NTK-711-8545N and NTK-711-8555N.Class II·Terminated·Baylis Medical Company Inc.·20191007
• Z-0085-2014 — Baylis Medical TorFlex Transseptal Guiding Sheath, Rx Only, non-pyrogenic, sterile. Product Usage: The TorFlex Transseptal Guiding Sheath kit (K102948) is a single use device consisting of three components: a sheath, a dilator, and a J-tipped guidewire. The kit is designed for safe and easy catheterization and angiography of specific heart chambers and locations.Class I·Terminated·Baylis Medical Corp *·20130923

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K102948.