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FDA 510(k)

OPEN TIP MULTI-ELECTRODE CATHETER, MODIFICATION

K-Number: K933451 · 1995-04-19

ApplicantElectro-Catheter Corp.
Decision Date1995-04-19
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OPEN TIP MULTI-ELECTRODE CATHETER, MODIFICATION 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 1995-04-19 under 510(k) number K933451. 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 OPEN TIP MULTI-ELECTRODE CATHETER, MODIFICATION?

OPEN TIP MULTI-ELECTRODE CATHETER, MODIFICATION is a medical device that received FDA 510(k) clearance on 1995-04-19. The listed applicant is Electro-Catheter Corp.. The 510(k) number is K933451.

When did OPEN TIP MULTI-ELECTRODE CATHETER, MODIFICATION receive FDA 510(k) clearance?

OPEN TIP MULTI-ELECTRODE CATHETER, MODIFICATION received FDA 510(k) clearance on 1995-04-19, under 510(k) number K933451.

Who is the listed applicant for OPEN TIP MULTI-ELECTRODE CATHETER, MODIFICATION?

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 OPEN TIP MULTI-ELECTRODE CATHETER, MODIFICATION?

The FDA product code for OPEN TIP MULTI-ELECTRODE CATHETER, MODIFICATION is DRF.

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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, MODIFICATIONK943257TIP DEFLECTOR (GENESIS)K934787SILICORE SEMI-FLOATERK874154ELECATH(R) TRANSESOPHAGEAL PACING CATHETERK854511ELECATH PERCUTANEOUS LEFT ATRIAL CANNULATION SET

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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

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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