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FDA 510(k)

MEDTRONIC BIO-MEDICUS CANNULA INSERTION KIT

K-Number: K924643 · 1992-12-08

ApplicantMedtronic Bio-Medicus, Inc.
Decision Date1992-12-08
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MEDTRONIC BIO-MEDICUS CANNULA INSERTION KIT is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Bio-Medicus, Inc.. It received FDA 510(k) clearance on 1992-12-08 under 510(k) number K924643. 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 MEDTRONIC BIO-MEDICUS CANNULA INSERTION KIT?

MEDTRONIC BIO-MEDICUS CANNULA INSERTION KIT is a medical device that received FDA 510(k) clearance on 1992-12-08. The listed applicant is Medtronic Bio-Medicus, Inc.. The 510(k) number is K924643.

When did MEDTRONIC BIO-MEDICUS CANNULA INSERTION KIT receive FDA 510(k) clearance?

MEDTRONIC BIO-MEDICUS CANNULA INSERTION KIT received FDA 510(k) clearance on 1992-12-08, under 510(k) number K924643.

Who is the listed applicant for MEDTRONIC BIO-MEDICUS CANNULA INSERTION KIT?

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

What is the FDA product code for MEDTRONIC BIO-MEDICUS CANNULA INSERTION KIT?

The FDA product code for MEDTRONIC BIO-MEDICUS CANNULA INSERTION KIT is DWF.

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Other records listing Medtronic 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.

K973237CSS-CARDIOPLEGIA SAFETY SYSTEMK973011BPX80 BIO-PUMP (BPX80)K954501BIOTREND OXYGEN SATURATION & HEMATOCRIT SYSTEMK941922MEDSAT OXYGEN SATURATION SYSTEMK936091MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 550M PUMP SPEED CONTROLLERK941921BIO-MEDICUS BIO-CONSOLE MODELS 540, 540A,B,C,D,E, & 550

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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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