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FDA 510(k)

ELECATH TORKFLOAT PACING PROBE

K-Number: K850065 · 1985-04-10

ApplicantElectro-Catheter Corp.
Decision Date1985-04-10
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ELECATH TORKFLOAT PACING PROBE 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 1985-04-10 under 510(k) number K850065. The device is classified under product code DTB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECATH TORKFLOAT PACING PROBE?

ELECATH TORKFLOAT PACING PROBE is a medical device that received FDA 510(k) clearance on 1985-04-10. The listed applicant is Electro-Catheter Corp.. The 510(k) number is K850065.

When did ELECATH TORKFLOAT PACING PROBE receive FDA 510(k) clearance?

ELECATH TORKFLOAT PACING PROBE received FDA 510(k) clearance on 1985-04-10, under 510(k) number K850065.

Who is the listed applicant for ELECATH TORKFLOAT PACING PROBE?

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 TORKFLOAT PACING PROBE?

The FDA product code for ELECATH TORKFLOAT PACING PROBE is DTB.

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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.

K934785MULTIPACEK933451OPEN TIP MULTI-ELECTRODE CATHETER, MODIFICATIONK943257TIP DEFLECTOR (GENESIS)K933450CLOSED TIP MULTI-ELECTRODE CATHETER, MODIFICATIONK934787SILICORE SEMI-FLOATERK874154ELECATH(R) TRANSESOPHAGEAL PACING CATHETER

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Related Devices (Code: DTB)

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.

K061212BIOTRONIK ENDOCARDIAL PACING LEADSBiotronik, Inc.K041809PERMANENT PACING LEAD, MODEL PY2Oscor, Inc.K040569PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJUOscor, Inc.K031274MODEL 5071 MYOCARDIAL PACING LEADMedtronic VascularK031210MODEL 4951M MYOCARDIAL UNIPOLAR LEADMetronic, Inc.K023205ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BPBiotronik, Inc.

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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