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FDA 510(k)

TEFLON COATED GUIDE WIRES & CATHETER

K-Number: K822586 · 1982-10-18

ApplicantUniversal Medical Instrument Corp.
Decision Date1982-10-18
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TEFLON COATED GUIDE WIRES & CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Universal Medical Instrument Corp.. It received FDA 510(k) clearance on 1982-10-18 under 510(k) number K822586. 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 TEFLON COATED GUIDE WIRES & CATHETER?

TEFLON COATED GUIDE WIRES & CATHETER is a medical device that received FDA 510(k) clearance on 1982-10-18. The listed applicant is Universal Medical Instrument Corp.. The 510(k) number is K822586.

When did TEFLON COATED GUIDE WIRES & CATHETER receive FDA 510(k) clearance?

TEFLON COATED GUIDE WIRES & CATHETER received FDA 510(k) clearance on 1982-10-18, under 510(k) number K822586.

Who is the listed applicant for TEFLON COATED GUIDE WIRES & CATHETER?

The FDA 510(k) record lists Universal Medical Instrument Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TEFLON COATED GUIDE WIRES & CATHETER?

The FDA product code for TEFLON COATED GUIDE WIRES & CATHETER is DQX.

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Other records listing Universal Medical Instrument Corp. 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.

K962180CATH SEALK935077CATH-SEALK897128UMI BRAIDED CATHETER CONNECTORK881796UMI DISPOSABLE BUTTERFLY STYLE PUNCTURE NEEDLEK863178UMI STEERABLE TORQUE GUIDE WIREK861984UMI CATH-SEAL, 13+14F & TRANSSEPTAL CATHETER INTRO

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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.

K253146Hyperdrive 35 GuidewireRapid-Medical , Ltd.K261281CROSSLEAD Standard 035 and CROSSLEAD Stiff 035Filmecc Co., Ltd.K253667Accoat Guide WireSp Medical A/SK261640Merit MAK Nitinol/Gold-Tungsten Guide WireMerit Medical Ireland , Ltd.K254137InQwire Amplatz Guide WireMerit Medical Ireland, Ltd.K260544FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40FMD Co., Ltd.

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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