510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K990284Substantially Equivalent

Baylis Medical RF Septostomy Generator, Nykanen RF Septostomy Catheter, Baylis Medical Connector Cable

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

K990284 is the FDA 510(k) clearance record for BAYLIS MEDICAL RF SEPTOSTOMY GENERATOR, NYKANEN RF SEPTOSTOMY CATHETER, BAYLIS MEDICAL CONNECTOR CABLE, 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 no recalls naming K990284.

Clearance record

Decision date
Received
(734 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. 5160 Explorer Dr., Unit 5, Mississauga, CA
510(k) summary
Statement
Third party review
No

Clearances, product code DXF

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