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FDA 510(k)

SLIM ART J. BIP PACING LEAD USING POLY #030-2821

K-Number: K852918 · 1985-07-29

ApplicantTelectronics, Inc.
Decision Date1985-07-29
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SLIM ART J. BIP PACING LEAD USING POLY #030-2821 is the device name listed in this FDA 510(k) record. The listed applicant is Telectronics, Inc.. It received FDA 510(k) clearance on 1985-07-29 under 510(k) number K852918. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SLIM ART J. BIP PACING LEAD USING POLY #030-2821?

SLIM ART J. BIP PACING LEAD USING POLY #030-2821 is a medical device that received FDA 510(k) clearance on 1985-07-29. The listed applicant is Telectronics, Inc.. The 510(k) number is K852918.

When did SLIM ART J. BIP PACING LEAD USING POLY #030-2821 receive FDA 510(k) clearance?

SLIM ART J. BIP PACING LEAD USING POLY #030-2821 received FDA 510(k) clearance on 1985-07-29, under 510(k) number K852918.

Who is the listed applicant for SLIM ART J. BIP PACING LEAD USING POLY #030-2821?

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

What is the FDA product code for SLIM ART J. BIP PACING LEAD USING POLY #030-2821?

The FDA product code for SLIM ART J. BIP PACING LEAD USING POLY #030-2821 is DYB.

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Related Devices (Code: DYB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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