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FDA 510(k)

SWITCHING UNIT ELECTRODE CATHETER

K-Number: K834602 · 1984-05-09

ApplicantWebster Laboratories, Inc.
Decision Date1984-05-09
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SWITCHING UNIT ELECTRODE CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Webster Laboratories, Inc.. It received FDA 510(k) clearance on 1984-05-09 under 510(k) number K834602. The device is classified under product code DRF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SWITCHING UNIT ELECTRODE CATHETER?

SWITCHING UNIT ELECTRODE CATHETER is a medical device that received FDA 510(k) clearance on 1984-05-09. The listed applicant is Webster Laboratories, Inc.. The 510(k) number is K834602.

When did SWITCHING UNIT ELECTRODE CATHETER receive FDA 510(k) clearance?

SWITCHING UNIT ELECTRODE CATHETER received FDA 510(k) clearance on 1984-05-09, under 510(k) number K834602.

Who is the listed applicant for SWITCHING UNIT ELECTRODE CATHETER?

The FDA 510(k) record lists Webster Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SWITCHING UNIT ELECTRODE CATHETER?

The FDA product code for SWITCHING UNIT ELECTRODE CATHETER is DRF.

Related Clinical Trials

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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Other records listing Webster Laboratories, 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.

K853383CARDIOVASCULAR, THERMODILUTION, FLOW, CORONARY SINK841802ELECTRODE CATHETER, ORTHOGONAL TYPEK823361SWITCHING UNIT ELECTRODE CATHETERSK813271TEMPERATURE PROBES

Related Devices (Code: DRF)

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.

K252794Vision-MR™ Diagnostic CatheterImricor Medical Systems, Inc.K250590MAGiC Sweep™ EP Mapping CatheterStereotaxis, Inc.K250310VIKING™ Fixed Curve Diagnostic CatheterBoston Scientific CorporationK240366EP•XT™ Unidirectional Steerable Diagnostic Catheter; Dynamic Tip™ Unidirectional Steerable Diagnostic Catheter; Dynamic XT™ Unidirectional Steerable Diagnostic CatheterBoston Scientific CorporationK233900Nordica PV Cryo Mapping CatheterSynaptic Medical CorporationK233397Cosine-10TM Diagnostic CatheterMedtronic, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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