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FDA 510(k)

TIP DEFLECTOR (GENESIS)

K-Number: K943257 · 1995-04-19

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

Device Summary

TIP DEFLECTOR (GENESIS) 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 K943257. 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 TIP DEFLECTOR (GENESIS)?

TIP DEFLECTOR (GENESIS) 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 K943257.

When did TIP DEFLECTOR (GENESIS) receive FDA 510(k) clearance?

TIP DEFLECTOR (GENESIS) received FDA 510(k) clearance on 1995-04-19, under 510(k) number K943257.

Who is the listed applicant for TIP DEFLECTOR (GENESIS)?

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 TIP DEFLECTOR (GENESIS)?

The FDA product code for TIP DEFLECTOR (GENESIS) 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 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, MODIFICATIONK933451OPEN TIP MULTI-ELECTRODE CATHETER, MODIFICATIONK934787SILICORE 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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