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FDA 510(k)

SWITCHING UNIT ELECTRODE CATHETERS

K-Number: K823361 · 1983-01-14

ApplicantWebster Laboratories, Inc.
Decision Date1983-01-14
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SWITCHING UNIT ELECTRODE CATHETERS 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 1983-01-14 under 510(k) number K823361. 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 CATHETERS?

SWITCHING UNIT ELECTRODE CATHETERS is a medical device that received FDA 510(k) clearance on 1983-01-14. The listed applicant is Webster Laboratories, Inc.. The 510(k) number is K823361.

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

SWITCHING UNIT ELECTRODE CATHETERS received FDA 510(k) clearance on 1983-01-14, under 510(k) number K823361.

Who is the listed applicant for SWITCHING UNIT ELECTRODE CATHETERS?

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 CATHETERS?

The FDA product code for SWITCHING UNIT ELECTRODE CATHETERS 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 TYPEK834602SWITCHING UNIT ELECTRODE CATHETERK813271TEMPERATURE 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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