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FDA 510(k)

COBE AIR EMBOLI PROTECTION SYSTEM (AEPS)

K-Number: K900910 · 1990-05-22

ApplicantCobe Laboratories, Inc.
Decision Date1990-05-22
Product CodeDTW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

COBE AIR EMBOLI PROTECTION SYSTEM (AEPS) is the device name listed in this FDA 510(k) record. The listed applicant is Cobe Laboratories, Inc.. It received FDA 510(k) clearance on 1990-05-22 under 510(k) number K900910. The device is classified under product code DTW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COBE AIR EMBOLI PROTECTION SYSTEM (AEPS)?

COBE AIR EMBOLI PROTECTION SYSTEM (AEPS) is a medical device that received FDA 510(k) clearance on 1990-05-22. The listed applicant is Cobe Laboratories, Inc.. The 510(k) number is K900910.

When did COBE AIR EMBOLI PROTECTION SYSTEM (AEPS) receive FDA 510(k) clearance?

COBE AIR EMBOLI PROTECTION SYSTEM (AEPS) received FDA 510(k) clearance on 1990-05-22, under 510(k) number K900910.

Who is the listed applicant for COBE AIR EMBOLI PROTECTION SYSTEM (AEPS)?

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

What is the FDA product code for COBE AIR EMBOLI PROTECTION SYSTEM (AEPS)?

The FDA product code for COBE AIR EMBOLI PROTECTION SYSTEM (AEPS) is DTW.

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Other records listing Cobe Laboratories, 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.

K923272COBE CMS-HF HOLLOW FIBER MEMBRANE OXYGENATORK900105COBE SPECTRA BLOOD COMPONENT SEPARATOR THERAPEUTICK905793COBE CENTRY 2 BICART OPTION KITK905388COBE CENTRYSYSTEM 3 BICART OPTION KITK904336NEW COBE SATURATION/HEMATOCRIT MONITORK902631COBE ICU CONVERSION KIT

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Related Devices (Code: DTW)

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.

K041558STOCKERTIR PURGE CONTROL (APC) SYSTEMStockert Instrumente GmbHK992857LEVELSENS - FLEXIBLE, MODEL 201110, LEVELSENS - RIGID, MODEL 201070Rocky Mountain Research, Inc.K955152STOCKERT S3 UPS, LVL CTRL BUBB. DET., DUAL PRESS. CTRL., TEMP MONT., TIMERStoeckert InstrumenteK910599CARDIOPULMONARY BYPASS LEVEL SENSING MONITORJtl Medical Corp.K924354STOCKERT CAPS LOW LEVEL DETECT II/BUBBLE MONITORSorin Biomedica, Fiat, USA, Inc.K915337CAPIOX LEVEL ALARMTerumo Medical Corp.

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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