Company · CA
Baylis Medical Co., Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1998 to 2025. Name variants (Inc, Corp, punctuation) are merged.
53510(k) clearances (0 in 12 months)
9recalls (0 in 12 months)
9recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DYB | Introducer, Catheter | 12 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 11 |
| GXI | Probe, Radiofrequency Lesion | 9 |
| DXF | Catheter, Septostomy | 6 |
| DQX | Wire, Guide, Catheter | 5 |
| DRE | Dilator, Vessel, For Percutaneous Catheterization | 5 |
| GXD | Generator, Lesion, Radiofrequency | 3 |
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | 2 |
| HRX | Arthroscope | 2 |
| PDU | Catheter For Crossing Total Occlusions | 2 |
| DBY | Fab, Rhodamine, Antigen, Antiserum, Control | 1 |
| DQY | Catheter, Percutaneous | 1 |
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | 1 |
| FMF | Syringe, Piston | 1 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 29, 2025 | K251325 | VersaCross Connect Transseptal Dilator Baylis Medical Company, Inc., CA | DRE |
| Nov 1, 2024 | K242076 | VersaCross RF Wire Baylis Medical Company, CA | DXF |
| Jul 12, 2024 | K241720 | VersaCross Connect Transseptal Dilator Baylis Medical Company, Inc., CA | DRE |
| Dec 20, 2023 | K231227 | SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath Baylis Medical Company, Inc., CA | DYB |
| Dec 14, 2023 | K233647 | VersaCross Connect Transseptal Dilator Baylis Medical Company, Inc., CA | DRE |
| Mar 1, 2023 | K213898 | ProTrack Pigtail Wire Baylis Medical Company, Inc., CA | DQX |
| Dec 19, 2022 | K221351 | Mechanical Guidewire Baylis Medical Company, Inc., CA | DQX |
| Jun 30, 2022 | K213582 | Epicardial Access System Baylis Medical Company, Inc., CA | DYB |
| May 9, 2022 | K220414 | VersaCross Connect Transseptal Dilator Baylis Medical Company, Inc., CA | DYB |
| Jun 12, 2020 | K201288 | ExpanSure Large Access Transseptal Dilator Baylis Medical Company, Inc., CA | DRE |
| Aug 2, 2019 | K191546 | Epicardial Access System Baylis Medical Company, Inc., CA | DYB |
| Jun 7, 2019 | K183649 | Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable Baylis Medical Company, Inc., CA | DRF |
| Jun 7, 2019 | K183632 | Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnostic Electrophysiology Cable Baylis Medical Company, Inc., CA | DRF |
| May 20, 2019 | K183655 | VersaCross Transseptal Sheath Baylis Medical Company, Inc., CA | DYB |
| Apr 17, 2019 | K190688 | VersaCross Steerable Sheath, VersaCross Transseptal Dilator Baylis Medical Company, Inc., CA | DYB |
| Mar 21, 2019 | K182064 | ExpanSure Transseptal Dilation System Baylis Medical Company, Inc., CA | DRE |
| Jan 2, 2019 | K181864 | Polaris RF Ablation System Baylis Medical Company, Inc., CA | GXD |
| Jan 31, 2017 | K161949 | OsteoCool V-3 RF Ablation System Baylis Medical Company, Inc., CA | GEI |
| Sep 26, 2016 | K161878 | PORTAGE System Baylis Medical Company, Inc., CA | HRX |
| Nov 24, 2015 | K152057 | OsteoCool V-3 RF Ablation System Baylis Medical Company, Inc., CA | GEI |
| Aug 18, 2015 | K151009 | Nexus Suture Baylis Medical Company, Inc., CA | GAT |
| Jun 17, 2015 | K150709 | ProTrack RF Anchor Wire Baylis Medical Company, Inc., CA | DXF |
| Jun 16, 2015 | K142480 | OsteoCool V-2 RF Ablation System Baylis Medical Company, Inc., CA | GEI |
| Aug 30, 2013 | K132374 | BAYLIS MEDICAL RF PERFORATION PROBE V2.0 Baylis Medical Company, Inc., CA | GEI |
| Jan 24, 2013 | K122926 | SUREFLEX STEERABLE GUIDING SHEATH KIT Baylis Medical Co., Inc., CA | DYB |
| Nov 7, 2012 | K122278 | BAYLIS MEDICAL COMPANY RADIOFREQUENCY PERFORATION GENERATOR Baylis Medical Company, Inc., CA | GEI |
| Mar 13, 2012 | K111523 | OSTEOCOOL (TM) RF ABLATION SYSTEM Baylis Medical Co., Inc., CA | GEI |
| Apr 1, 2011 | K102948 | TORFLEX TRANSSEPTAL GUIDING SHEATH Baylis Medical Co., Inc., CA | DYB |
| Feb 23, 2011 | K102192 | INDISCAL DIGITAL MANOMETER Baylis Medical Co., Inc., CA | FMF |
| Aug 10, 2010 | K101372 | DUOCOOL PAIN MANAGEMENT PROBE, MODEL OSP-17-180-20 Baylis Medical Co., Inc., CA | GXI |
| Jul 28, 2010 | K101615 | POWERWIRE RADIOFREQUENCY GUIDEWIRE Baylis Medical Co., Inc., CA | PDU |
| Jul 16, 2010 | K101117 | LEV-OR DILATION CATHETER OTW Baylis Medical Co., Inc., CA | DQY |
| Nov 17, 2009 | K092877 | INDISCAL ASPIRATION DEVICE AND ACCESSORIES Baylis Medical Co., Inc., CA | HRX |
| Oct 16, 2009 | K092337 | PAIN MANAGEMENT OPTIMA, MODEL PMO21-100-05, PMO20-100-10CS, PMO20-145-10CS Baylis Medical Co., Inc., CA | GXI |
| May 28, 2008 | K073326 | NRG TRANSSEPTAL NEEDLE Baylis Medical Co., Inc., CA | DXF |
| Dec 19, 2007 | K072478 | BAYLIS PAIN MANAGEMENT GENERATOR-TD, MODELS: PMG-115-TD AND PMG-230-TD Baylis Medical Co., Inc., CA | GEI |
| Jul 19, 2007 | K071745 | BAYLIS PAIN MANAGEMENT SINGLE-USE PROBE Baylis Medical Co., Inc., CA | GXI |
| Jan 8, 2007 | K062937 | TRANSDISCAL SYSTEM, MODELS TDP-17-150-6, TDI-17-150, TDA-PPU-1, TDA-TBK-1, TDX-Y-TSW-TDP, TDX-PMG-PPU Baylis Medical Co., Inc., CA | GXI |
| Mar 30, 2006 | K051670 | RF TUNNELER WIRE Baylis Medical Co., Inc., CA | PDU |
| Nov 30, 2005 | K053082 | BAYLIS PAIN MANAGEMENT COOLED PROBE, MODEL PMPC-18-150-6 Baylis Medical Co., Inc., CA | GXI |
| Dec 10, 2003 | K031949 | TORONTO RF SEPTOSTOMY CATHETER, MODEL TSC-50-75 Baylis Medical Co., Inc., CA | DXF |
| Sep 11, 2003 | K031951 | TRANSDISCAL SYSTEM (TRANSDISCAL PROBE), MODEL TDP-17-150-6 Baylis Medical Co., Inc., CA | GEI |
| Jul 17, 2003 | K031950 | BAYLIS PAIN MANAGEMENT GENERATOR, MODELS PMG-115-TD AND PMG-230-TD Baylis Medical Co., Inc., CA | GEI |
| Dec 31, 2002 | K023334 | BMC CATHETER CONNECTOR CABLE, MODEL RFP-101 Baylis Medical Co., Inc., CA | DSA |
| May 3, 2002 | K020354 | BAYLIS PAIN MANAGEMENT GENERATOR (PMG), MODELS PMG-115 (DOMESTIC), PMG-230 (INTERNATIONAL) Baylis Medical Co., Inc., CA | GXD |
| Mar 7, 2002 | K014075 | BMC COAXIAL INJECTABLE CATHETER, MODEL CIC 38/145 AND CIC 35/145 Baylis Medical Co., Inc., CA | DQX |
| Feb 22, 2002 | K013919 | TORFLEX TRANSSEPTAL GUIDING SHEATH Baylis Medical Co., Inc., CA | DBY |
| Feb 12, 2002 | K013904 | BMC RADIO FREQUENCY PERFORATION GENERATOR, MODELS RFP-100-115 AND RFP-100-230 Baylis Medical Co., Inc., CA | GEI |
| May 3, 2001 | K002565 | BAYLIS PAIN MANAGEMENT GENERATOR MODEL: PMG-115 (FOR DOMESTIC USE), PMG-230 (FOR INTERNATIONAL USE) Baylis Medical Co., Inc., CA | GXD |
| Apr 9, 2001 | K010265 | BAYLIS MEDICAL RF PERFORATION PROBE, MODEL RFP-265 Baylis Medical Co., Inc., CA | GEI |
Newest 50 of 53.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 21, 2020 | Baylis Medical Company Inc. 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 Terminated |
DYB | K102948 |
| May 21, 2020 | Baylis Medical Company Inc. 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, T Terminated |
DYB | K102948 |
| Nov 10, 2016 | Baylis Medical Corp * NRG Transseptal Needle and NRG RF Transseptal Kit.
Model/Catalogue Numbers: NRG-56-32-C0, NRG-71-C0, NRG-71-C1, NRG-89-C0, NRG-89-C1, NRG-98-C0, NRG-98-C1, NRG-98-C1-T, NRG-E-56-32-C0, and NRG-E-HF- Terminated |
DXF | K073326 |
| Dec 1, 2015 | Baylis Medical Corp * ProTrack Microcatheter. Model/Catalog Numbers CIC38-145, CIC35-145. Sterile, single use device intended to be used as a standard infusion wire or as an exchange guide for exchanging guidewires. Coa Terminated |
DQX | K014075 |
| Apr 13, 2015 | Baylis Medical Corp * ProTrack Microcatheter;
Product Usage: The ProTrack Microcatheter is a sterile, single use device intended to be used as a standard infusion wire or as an exchange guide for exchanging guidewires. Terminated |
DQX | K014075 |
| Nov 1, 2013 | Baylis Medical Corp * 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 com Terminated |
DYB | K102948 |
| Feb 26, 2013 | Baylis Medical Company Inc. BMC RF Cannula Curved Sharp RadiOpaque, Non-Pyrogenic, Active Tip: 10mm, Gauge 16 Ga, Length: 100mm. The BMC RF Cannula is sealed in a Tyvek pouch (primary packaging) and then placed into a white she Terminated |
GXI | K972846 |
| Jun 3, 2010 | Baylis Medical Corp * The Baylis LumbarCool Pain Management Kit consisting of: 1 LumbarCool Pain Management Probe, 3 LumbarCool Pain Management introducers, and 1 Pain Management Tube Kit. Model/Catalogue Number: LUK-17-1 Terminated |
GXI | K053082 K062937 |
| Mar 10, 2010 | Baylis Medical Corp * Torflex Transseptal Guiding Sheath, Baylis Medical Company Inc., 5959 Trans-Canada Highway, Montreal, QC, Canada H4T1A1, (514) 488-9802; INCLUDES: One (1) Radiopaque Sheath, One (1) Radiopaque Dilator Terminated |
DYB | K013919 |