510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K073326Substantially Equivalent

Nrg Transseptal Needle

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

K073326 is the FDA 510(k) clearance record for NRG TRANSSEPTAL NEEDLE, a class II device, cleared for Baylis Medical Co., Inc. on under FDA product code DXF (Catheter, Septostomy). FDA records list 53 510(k) clearances for Baylis Medical Co., Inc., from to . As of , FDA records show one recall naming K073326.

Clearance record

Decision date
Received
(183 days to decision)
Product code
DXF Catheter, Septostomy
Regulation
21 CFR 870.5175
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 DXF

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