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FDA 510(k)

SELECTRA SLITTER TOOL

K-Number: K112482 · 2011-09-26

ApplicantBiotronik, Inc.
Decision Date2011-09-26
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SELECTRA SLITTER TOOL is the device name listed in this FDA 510(k) record. The listed applicant is Biotronik, Inc.. It received FDA 510(k) clearance on 2011-09-26 under 510(k) number K112482. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SELECTRA SLITTER TOOL?

SELECTRA SLITTER TOOL is a medical device that received FDA 510(k) clearance on 2011-09-26. The listed applicant is Biotronik, Inc.. The 510(k) number is K112482.

When did SELECTRA SLITTER TOOL receive FDA 510(k) clearance?

SELECTRA SLITTER TOOL received FDA 510(k) clearance on 2011-09-26, under 510(k) number K112482.

Who is the listed applicant for SELECTRA SLITTER TOOL?

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 SELECTRA SLITTER TOOL?

The FDA product code for SELECTRA SLITTER TOOL is DQY.

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Other records listing Biotronik, Inc. as applicant

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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Related Devices (Code: DQY)

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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