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FDA 510(k)

KENDALL INFANT ECMO VENOVENOUS CATHETER-DUAL LUMEN

K-Number: K895352 · 1989-11-29

Decision Date1989-11-29
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

KENDALL INFANT ECMO VENOVENOUS CATHETER-DUAL LUMEN is the device name listed in this FDA 510(k) record. The listed applicant is Kendall Healthcare Products Co. Div.Of Tyco Health. It received FDA 510(k) clearance on 1989-11-29 under 510(k) number K895352. 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 KENDALL INFANT ECMO VENOVENOUS CATHETER-DUAL LUMEN?

KENDALL INFANT ECMO VENOVENOUS CATHETER-DUAL LUMEN is a medical device that received FDA 510(k) clearance on 1989-11-29. The listed applicant is Kendall Healthcare Products Co. Div.Of Tyco Health. The 510(k) number is K895352.

When did KENDALL INFANT ECMO VENOVENOUS CATHETER-DUAL LUMEN receive FDA 510(k) clearance?

KENDALL INFANT ECMO VENOVENOUS CATHETER-DUAL LUMEN received FDA 510(k) clearance on 1989-11-29, under 510(k) number K895352.

Who is the listed applicant for KENDALL INFANT ECMO VENOVENOUS CATHETER-DUAL LUMEN?

The FDA 510(k) record lists Kendall Healthcare Products Co. Div.Of Tyco Health as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KENDALL INFANT ECMO VENOVENOUS CATHETER-DUAL LUMEN?

The FDA product code for KENDALL INFANT ECMO VENOVENOUS CATHETER-DUAL LUMEN is DWF.

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.

Other records listing Kendall Healthcare Products Co. Div.Of Tyco Health 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.

View all 66 devices →

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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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