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FDA 510(k)

TORONTO RF SEPTOSTOMY CATHETER, MODEL TSC-50-75

K-Number: K031949 · 2003-12-10

ApplicantBaylis Medical Co., Inc.
Decision Date2003-12-10
Product CodeDXF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TORONTO RF SEPTOSTOMY CATHETER, MODEL TSC-50-75 is the device name listed in this FDA 510(k) record. The listed applicant is Baylis Medical Co., Inc.. It received FDA 510(k) clearance on 2003-12-10 under 510(k) number K031949. The device is classified under product code DXF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TORONTO RF SEPTOSTOMY CATHETER, MODEL TSC-50-75?

TORONTO RF SEPTOSTOMY CATHETER, MODEL TSC-50-75 is a medical device that received FDA 510(k) clearance on 2003-12-10. The listed applicant is Baylis Medical Co., Inc.. The 510(k) number is K031949.

When did TORONTO RF SEPTOSTOMY CATHETER, MODEL TSC-50-75 receive FDA 510(k) clearance?

TORONTO RF SEPTOSTOMY CATHETER, MODEL TSC-50-75 received FDA 510(k) clearance on 2003-12-10, under 510(k) number K031949.

Who is the listed applicant for TORONTO RF SEPTOSTOMY CATHETER, MODEL TSC-50-75?

The FDA 510(k) record lists Baylis Medical Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TORONTO RF SEPTOSTOMY CATHETER, MODEL TSC-50-75?

The FDA product code for TORONTO RF SEPTOSTOMY CATHETER, MODEL TSC-50-75 is DXF.

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Related Devices (Code: DXF)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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