510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K101615Substantially Equivalent

Powerwire Radiofrequency Guidewire

Baylis Medical Co., Inc., Mississauga, Ontario, CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K101615 is the FDA 510(k) clearance record for POWERWIRE RADIOFREQUENCY GUIDEWIRE, a class II device, cleared for Baylis Medical Co., Inc. on under FDA product code PDU (Catheter For Crossing Total Occlusions). FDA's definition for product code PDU reads: "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...". FDA records list 53 510(k) clearances for Baylis Medical Co., Inc., from to . As of , FDA records show no recalls naming K101615.

Clearance record

Decision date
Received
(49 days to decision)
Product code
PDU Catheter For Crossing Total Occlusions
Regulation
21 CFR 870.1250
Device class
Class II
Review panel
Cardiovascular
Applicant
Baylis Medical Co., Inc. 2645 Matheson Blvd. E., Mississauga, Ontario, CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PDU

Trailing 12 months
1 clearance under product code PDU in the twelve months to October 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PDU, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260