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FDA 510(k)

SLIM VENT BIPO PACING LEAD USING A90 INSUL,#30-284

K-Number: K852916 · 1985-07-29

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

Device Summary

SLIM VENT BIPO PACING LEAD USING A90 INSUL,#30-284 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 K852916. 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 VENT BIPO PACING LEAD USING A90 INSUL,#30-284?

SLIM VENT BIPO PACING LEAD USING A90 INSUL,#30-284 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 K852916.

When did SLIM VENT BIPO PACING LEAD USING A90 INSUL,#30-284 receive FDA 510(k) clearance?

SLIM VENT BIPO PACING LEAD USING A90 INSUL,#30-284 received FDA 510(k) clearance on 1985-07-29, under 510(k) number K852916.

Who is the listed applicant for SLIM VENT BIPO PACING LEAD USING A90 INSUL,#30-284?

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 VENT BIPO PACING LEAD USING A90 INSUL,#30-284?

The FDA product code for SLIM VENT BIPO PACING LEAD USING A90 INSUL,#30-284 is DYB.

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Other records listing Telectronics, Inc. as applicant

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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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