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FDA 510(k)

CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

K-Number: K953750 · 1996-03-11

ApplicantBoston Scientific Corp
Decision Date1996-03-11
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corp. It received FDA 510(k) clearance on 1996-03-11 under 510(k) number K953750. 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 CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING?

CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING is a medical device that received FDA 510(k) clearance on 1996-03-11. The listed applicant is Boston Scientific Corp. The 510(k) number is K953750.

When did CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING receive FDA 510(k) clearance?

CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING received FDA 510(k) clearance on 1996-03-11, under 510(k) number K953750.

Who is the listed applicant for CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING?

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

What is the FDA product code for CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING?

The FDA product code for CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING is DRF.

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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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