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FDA 510(k)

A1-CS-SB Y-ADAPTER, MODEL 124 871

K-Number: K003454 · 2001-01-18

ApplicantBiotronik, Inc.
Decision Date2001-01-18
Product CodeDTD
Advisory CommitteeCV
DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

A1-CS-SB Y-ADAPTER, MODEL 124 871 is the device name listed in this FDA 510(k) record. The listed applicant is Biotronik, Inc.. It received FDA 510(k) clearance on 2001-01-18 under 510(k) number K003454. The device is classified under product code DTD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent - Subject to Tracking Reg..

Frequently Asked Questions

What is the A1-CS-SB Y-ADAPTER, MODEL 124 871?

A1-CS-SB Y-ADAPTER, MODEL 124 871 is a medical device that received FDA 510(k) clearance on 2001-01-18. The listed applicant is Biotronik, Inc.. The 510(k) number is K003454.

When did A1-CS-SB Y-ADAPTER, MODEL 124 871 receive FDA 510(k) clearance?

A1-CS-SB Y-ADAPTER, MODEL 124 871 received FDA 510(k) clearance on 2001-01-18, under 510(k) number K003454.

Who is the listed applicant for A1-CS-SB Y-ADAPTER, MODEL 124 871?

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

What is the FDA product code for A1-CS-SB Y-ADAPTER, MODEL 124 871?

The FDA product code for A1-CS-SB Y-ADAPTER, MODEL 124 871 is DTD.

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Related Devices (Code: DTD)

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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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