FDA.reportPublic FDA data

PowerWire Pro Radiofrequency Guidewire Kit

Primary DI
07540299000419
Brand
PowerWire Pro Radiofrequency Guidewire Kit
Company
Baylis Medical Technologies Inc
Model
PSK35-250-12-6S
Device description
PowerWire Pro RF Guidewire; RFP-100A Connector Cable
Published
2024-03-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DSACable, Transducer And Electrode, Patient, (Including Connector)
PDUCatheter For Crossing Total Occlusions

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSACable, Transducer And Electrode, Patient, (Including Connector)Cardiovascular2
PDUCatheter For Crossing Total OcclusionsCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232562000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232562000PowerWire Radiofrequency Guidewire KitBaylis Medical Technologies, Inc.2024-02-28PDU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07540299000419PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540299000419075402990004197540299000419

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical electrode, monopolar, single-useA sterile, invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a monopolar configuration (i.e., used with a patient contact return electrode) to tissues for cutting/coagulation/ablation during endoscopic (e.g., laparoscopic, arthroscopic) surgery. It is available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps, rigid electrode, flexible endoscopic probe) which may include a lumen for suction/irrigation. It does not include a handpiece or housing and has no electrical or mechanical controls (e.g., does not include ring-handles); it is not intended for gas-enhanced electrosurgery. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
905-948-5800info@baylismedtech.com

Regulatory Flags#

DUNS number
240389677
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07540299000426PowerWire 14 Radiofrequency Guidewire KitPW14-190-S2025-12-04
07540299000433PowerWire 14 Radiofrequency Guidewire KitPW14-300-S2025-12-04
07540299000471PowerWire 14 Radiofrequency Guidewire KitPW14-190-20A2025-12-04
07540299000488PowerWire 14 Radiofrequency Guidewire KitPW14-300-20A2025-12-04
07540299000440 PowerWire Pulse RF Guidewire KitPTK35-250-08-6S2024-09-27
07540299000457 PowerWire Pulse RF Guidewire KitPTK35-250-10-6S2024-09-27
07540299000464 PowerWire Pulse RF Guidewire KitPTK35-250-12-6S2024-09-27
07540299000020AnchorKnot SutureASU-0-W-CL2022-11-16
07540299000037AnchorKnot SutureASU-2-0-WB-CL2022-11-16
07540299000044AnchorKnot SutureASU-2-0-W-CL2022-11-16
07540299000051AnchorKnot SutureASU-2-WB-CL2022-11-16
07540299000068AnchorKnot SutureASU-2-W-CL2022-11-16
07540299000013AnchorKnot SutureASU-0-WB-CL2022-11-16
07540299000075AnchorKnot SutureASU-0-WB-LR2022-11-16
07540299000082AnchorKnot SutureASU-0-W-LR2022-11-16
07540299000099AnchorKnot SutureASU-2-0-WB-LR2022-11-16
07540299000105AnchorKnot SutureASU-2-0-W-LR2022-11-16
07540299000112AnchorKnot SutureASU-2-WB-LR2022-11-16
07540299000129AnchorKnot SutureASU-2-W-LR2022-11-16
07540299000136AnchorKnot Suture Passer (2-0) PSZ-400-3052022-11-16

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Primary DI, Brand, Company table
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00840416606935FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-06-02
00840416606942FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-06-02
00840416606959FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-06-02
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08719689142261QMAPP Fysicon B.V.DSA2026-05-19
08719689142322QMAPPFysicon B.V.DSA2026-05-19
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08719689142360QMAPPFysicon B.V.DSA2026-05-19
08719689142377QMAPPFysicon B.V.DSA2026-05-19
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08719689142391QMAPPFysicon B.V.DSA2026-05-19
08719689142407QMAPPFysicon B.V.DSA2026-05-19
08719689142414QMAPPFysicon B.V.DSA2026-05-19
08719689142469QMAPPFysicon B.V.DSA2026-05-19
08719689142476QMAPPFysicon B.V.DSA2026-05-19
08719689142483QMAPPFysicon B.V.DSA2026-05-19
08719689142490QMAPPFysicon B.V.DSA2026-05-19
08719689142506QMAPPFysicon B.V.DSA2026-05-19
08719689142513QMAPPFysicon B.V.DSA2026-05-19
08719689142520QMAPPFysicon B.V.DSA2026-05-19