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FDA 510(k)

COBE CATHETER W/GUIDEWIRE ASSEMBLY KIT

K-Number: K853100 · 1985-09-25

ApplicantCobe Laboratories, Inc.
Decision Date1985-09-25
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

COBE CATHETER W/GUIDEWIRE ASSEMBLY KIT 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 1985-09-25 under 510(k) number K853100. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COBE CATHETER W/GUIDEWIRE ASSEMBLY KIT?

COBE CATHETER W/GUIDEWIRE ASSEMBLY KIT is a medical device that received FDA 510(k) clearance on 1985-09-25. The listed applicant is Cobe Laboratories, Inc.. The 510(k) number is K853100.

When did COBE CATHETER W/GUIDEWIRE ASSEMBLY KIT receive FDA 510(k) clearance?

COBE CATHETER W/GUIDEWIRE ASSEMBLY KIT received FDA 510(k) clearance on 1985-09-25, under 510(k) number K853100.

Who is the listed applicant for COBE CATHETER W/GUIDEWIRE ASSEMBLY KIT?

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 CATHETER W/GUIDEWIRE ASSEMBLY KIT?

The FDA product code for COBE CATHETER W/GUIDEWIRE ASSEMBLY KIT is DYB.

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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: DYB)

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.

K253526NAMIC Dilator and SheathMedline Industries, LPK261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04)Hartman Medical Group, LLCK261242SimplGuidePendracareK261950Health Line Tearaway IntroducerHealth Line International CorporationK261492FieldFlex Steerable SheathCenterPoint Systems, LLCK260606Echo Large Bore Introducer SheathEcho Medical, LLC

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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