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FDA 510(k)

CARDIOPULMONARY CANNULA TUBING

K-Number: K861096 · 1986-05-21

ApplicantBio Medicus, Inc.
Decision Date1986-05-21
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOPULMONARY CANNULA TUBING is the device name listed in this FDA 510(k) record. The listed applicant is Bio Medicus, Inc.. It received FDA 510(k) clearance on 1986-05-21 under 510(k) number K861096. 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 CARDIOPULMONARY CANNULA TUBING?

CARDIOPULMONARY CANNULA TUBING is a medical device that received FDA 510(k) clearance on 1986-05-21. The listed applicant is Bio Medicus, Inc.. The 510(k) number is K861096.

When did CARDIOPULMONARY CANNULA TUBING receive FDA 510(k) clearance?

CARDIOPULMONARY CANNULA TUBING received FDA 510(k) clearance on 1986-05-21, under 510(k) number K861096.

Who is the listed applicant for CARDIOPULMONARY CANNULA TUBING?

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

What is the FDA product code for CARDIOPULMONARY CANNULA TUBING?

The FDA product code for CARDIOPULMONARY CANNULA TUBING is DWF.

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Other records listing Bio Medicus, 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.

K920761URINE CULTUR STABILIZATION TRANSPORT TUBEK903410BIO-MEDICUS CANNULA INTRODUCERK901253(PBS) PORTABLE BYPASS SYSTEM, MODEL 1000K901584BIO-MEDICUS BIO CONSOLE MODELS 540 A B CK894980BIO-CAL 370 HEATER/COOLERK884129BIO-MEDICUS PERCUTANEOUS CANNULA & INTRODUCER SET

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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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