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FDA 510(k)

SOFTIP CORONARY SINUS CARDIOPLEGIA CATHETER

K-Number: K863342 · 1987-03-03

ApplicantAngiomedics, Inc.
Decision Date1987-03-03
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SOFTIP CORONARY SINUS CARDIOPLEGIA CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Angiomedics, Inc.. It received FDA 510(k) clearance on 1987-03-03 under 510(k) number K863342. The device is classified under product code DWF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOFTIP CORONARY SINUS CARDIOPLEGIA CATHETER?

SOFTIP CORONARY SINUS CARDIOPLEGIA CATHETER is a medical device that received FDA 510(k) clearance on 1987-03-03. The listed applicant is Angiomedics, Inc.. The 510(k) number is K863342.

When did SOFTIP CORONARY SINUS CARDIOPLEGIA CATHETER receive FDA 510(k) clearance?

SOFTIP CORONARY SINUS CARDIOPLEGIA CATHETER received FDA 510(k) clearance on 1987-03-03, under 510(k) number K863342.

Who is the listed applicant for SOFTIP CORONARY SINUS CARDIOPLEGIA CATHETER?

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

What is the FDA product code for SOFTIP CORONARY SINUS CARDIOPLEGIA CATHETER?

The FDA product code for SOFTIP CORONARY SINUS CARDIOPLEGIA CATHETER is DWF.

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Other records listing Angiomedics, 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.

K873195SCHNEIDER-SHILEY ANGIOPORT(TM) PTCA INTRO W/HEMOK872542SCHNEIDER-SHILEY SOFTRAC-PTA(TM) ANGIO. CATHETERK872472SCHNEIDER-SHILEY BIFLATOR BALLOON INFLATION DEVICEK861238ANGIOMEDICS CATH SHEATH INTRODUC W/HEMOSTASIS VALVK852872ANGIOMEDICS SOFTIP CATHETERK850271ANGIOMEDIC'S CATHETER-DIAGNOSTIC INTRAVASCULAR

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Related Devices (Code: DWF)

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.

K260195Elongated One-Piece Arterial (EOPA) 3D™ Arterial CannulaeMedtronic, Inc.K250937Venous Return CannulaeLivaNova USA, Inc.K260043Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)Smart ReactorsK253203Retrograde Coronary Sinus Perfusion CannulaeMedtronic, Inc.K253671Dual Stage Venous CannulaeSorin Group Italia S.R.L.K253998Clearview Intracoronary ShuntsMedtronic, 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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