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FDA 510(k)

ELECATH PLASTIC JACKETED GUIDEWIRE

K-Number: K780493 · 1978-04-10

ApplicantElectro-Catheter Corp.
Decision Date1978-04-10
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ELECATH PLASTIC JACKETED GUIDEWIRE is the device name listed in this FDA 510(k) record. The listed applicant is Electro-Catheter Corp.. It received FDA 510(k) clearance on 1978-04-10 under 510(k) number K780493. 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 ELECATH PLASTIC JACKETED GUIDEWIRE?

ELECATH PLASTIC JACKETED GUIDEWIRE is a medical device that received FDA 510(k) clearance on 1978-04-10. The listed applicant is Electro-Catheter Corp.. The 510(k) number is K780493.

When did ELECATH PLASTIC JACKETED GUIDEWIRE receive FDA 510(k) clearance?

ELECATH PLASTIC JACKETED GUIDEWIRE received FDA 510(k) clearance on 1978-04-10, under 510(k) number K780493.

Who is the listed applicant for ELECATH PLASTIC JACKETED GUIDEWIRE?

The FDA 510(k) record lists Electro-Catheter Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELECATH PLASTIC JACKETED GUIDEWIRE?

The FDA product code for ELECATH PLASTIC JACKETED GUIDEWIRE is DQX.

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Other records listing Electro-Catheter 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.

K934785MULTIPACEK933450CLOSED TIP MULTI-ELECTRODE CATHETER, MODIFICATIONK933451OPEN TIP MULTI-ELECTRODE CATHETER, MODIFICATIONK943257TIP DEFLECTOR (GENESIS)K934787SILICORE SEMI-FLOATERK874154ELECATH(R) TRANSESOPHAGEAL PACING CATHETER

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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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