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FDA 510(k)

BARD PTFE (TEFLON) COATED GUIDE WIRES

K-Number: K082094 · 2008-12-17

ApplicantC.R. Bard Inc., Bard Electrophysiology Division
Decision Date2008-12-17
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BARD PTFE (TEFLON) COATED GUIDE WIRES is the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard Inc., Bard Electrophysiology Division. It received FDA 510(k) clearance on 2008-12-17 under 510(k) number K082094. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BARD PTFE (TEFLON) COATED GUIDE WIRES?

BARD PTFE (TEFLON) COATED GUIDE WIRES is a medical device that received FDA 510(k) clearance on 2008-12-17. The listed applicant is C.R. Bard Inc., Bard Electrophysiology Division. The 510(k) number is K082094.

When did BARD PTFE (TEFLON) COATED GUIDE WIRES receive FDA 510(k) clearance?

BARD PTFE (TEFLON) COATED GUIDE WIRES received FDA 510(k) clearance on 2008-12-17, under 510(k) number K082094.

Who is the listed applicant for BARD PTFE (TEFLON) COATED GUIDE WIRES?

The FDA 510(k) record lists C.R. Bard Inc., Bard Electrophysiology Division as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BARD PTFE (TEFLON) COATED GUIDE WIRES?

The FDA product code for BARD PTFE (TEFLON) COATED GUIDE WIRES is DQX.

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Other records listing C.R. Bard Inc., Bard Electrophysiology Division as applicant

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Related Devices (Code: DQX)

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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