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FDA 510(k)

RESPONSE(TM) STEERABLE CATHETER

K-Number: K913940 · 1993-01-26

ApplicantDaig Corp.
Decision Date1993-01-26
Product CodeDRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RESPONSE(TM) STEERABLE CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Daig Corp.. It received FDA 510(k) clearance on 1993-01-26 under 510(k) number K913940. The device is classified under product code DRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESPONSE(TM) STEERABLE CATHETER?

RESPONSE(TM) STEERABLE CATHETER is a medical device that received FDA 510(k) clearance on 1993-01-26. The listed applicant is Daig Corp.. The 510(k) number is K913940.

When did RESPONSE(TM) STEERABLE CATHETER receive FDA 510(k) clearance?

RESPONSE(TM) STEERABLE CATHETER received FDA 510(k) clearance on 1993-01-26, under 510(k) number K913940.

Who is the listed applicant for RESPONSE(TM) STEERABLE CATHETER?

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

What is the FDA product code for RESPONSE(TM) STEERABLE CATHETER?

The FDA product code for RESPONSE(TM) STEERABLE CATHETER is DRA.

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Other records listing Daig 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.

K000004ALLIANCE LEFT HEART DELIVERY SYSTEM INTRODUCER, MODEL #407509K994334ULTRA-FLEX HEMOSTASIS INTRODUCER. MODEL 406XXXK982299SPYGLASS 5 FR ANGIOGRAPHIC CATHETERK982187FAST-CATH INTRA-CARDIAC INTRODUCERK973840FAST-CATH (TM) INTRA-CARDIAC INTRODUCERK964518FAST-CATH TRANSSEPTAL CATHETER INTRODUCER

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Related Devices (Code: DRA)

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.

K262165FARADRIVE™ Steerable Sheath (M004PF21M402)Boston Scientific CorporationK250529Globe Introducer (601-01001)Kardium, Inc.K233248FARADRIVE™ Steerable SheathBoston Scientific CorporationK232321FlexCath Contour™ Steerable SheathMedtronic, Inc.K223824POLARSHEATH™ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP™ Circular Mapping Catheter (UPN:M004CRBS7210), POLARMAP™ EP Electrical Cable (UPN:M004CRBS62000), SMARTFREEZE™ Esophageal Temperature Sensor (ETS) Cable: -SMARTFREEZE™ Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6310), -SMARTFREEZE™ 16 PIN Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6320), -SMARTFREEZE™ CIRCA Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6340), SMARTFREEZE™ Pressure SensorBoston Scientific CorporationK221397MitraClip G4 Steerable Guide CatheterABBOTT MEDICAL

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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