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510(k) K101615

POWERWIRE RADIOFREQUENCY GUIDEWIRE by Baylis Medical Co., Inc. — Product Code PDU

K101615 is an FDA 510(k) premarket notification submitted by Baylis Medical Co., Inc. for the device "POWERWIRE RADIOFREQUENCY GUIDEWIRE". The FDA issued a decision of Substantially Equivalent on July 28, 2010. The device falls under product code PDU (Catheter For Crossing Total Occlusions), a Class II device regulated under 21 CFR 870.1250. Baylis Medical Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 2010
Date Received
June 9, 2010
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter For Crossing Total Occlusions
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type

To facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including subchronic and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention, such as angioplasty, atherectomy or stent placement.

Other clearances by Baylis Medical Co., Inc.

  • K122926 — SUREFLEX STEERABLE GUIDING SHEATH KIT (January 24, 2013)
  • K111523 — OSTEOCOOL (TM) RF ABLATION SYSTEM (March 13, 2012)
  • K102948 — TORFLEX TRANSSEPTAL GUIDING SHEATH (April 1, 2011)
  • K102192 — INDISCAL DIGITAL MANOMETER (February 23, 2011)
  • K101372 — DUOCOOL PAIN MANAGEMENT PROBE, MODEL OSP-17-180-20 (August 10, 2010)
  • K101117 — LEV-OR DILATION CATHETER OTW (July 16, 2010)
  • K092877 — INDISCAL ASPIRATION DEVICE AND ACCESSORIES (November 17, 2009)
  • K092337 — PAIN MANAGEMENT OPTIMA, MODEL PMO21-100-05, PMO20-100-10CS, PMO20-145-10CS (October 16, 2009)
  • K073326 — NRG TRANSSEPTAL NEEDLE (May 28, 2008)
  • K072478 — BAYLIS PAIN MANAGEMENT GENERATOR-TD, MODELS: PMG-115-TD AND PMG-230-TD (December 19, 2007)

Other clearances for product code PDU

  • K252315 — Santreva™-ATK Endovascular Revasculariztion Catheter (September 22, 2025)
  • K251158 — PowerWire® 14 Radiofrequency Guidewire Kit (September 11, 2025)
  • K251376 — LimFlow ARC (May 31, 2025)
  • K232562 — PowerWire Radiofrequency Guidewire Kit (February 28, 2024)
  • K230159 — SoundBite® Crossing System XS Peripheral (August 28, 2023)
  • K230594 — Tigereye ST CTO-Crossing Catheter (April 25, 2023)
  • K221163 — Tunnel Crossing Catheter (January 19, 2023)
  • K221541 — LimFlow ARC (August 31, 2022)
  • K220544 — DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2. (June 29, 2022)
  • K211802 — GoBack Crossing Catheter (March 1, 2022)

FDA data resources