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FDA 510(k)

CARDIAC CATHETERIZATION PACK

K-Number: K850337 · 1985-02-25

ApplicantMarwood Medical, Inc.
Decision Date1985-02-25
Product CodeDRE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIAC CATHETERIZATION PACK is the device name listed in this FDA 510(k) record. The listed applicant is Marwood Medical, Inc.. It received FDA 510(k) clearance on 1985-02-25 under 510(k) number K850337. The device is classified under product code DRE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIAC CATHETERIZATION PACK?

CARDIAC CATHETERIZATION PACK is a medical device that received FDA 510(k) clearance on 1985-02-25. The listed applicant is Marwood Medical, Inc.. The 510(k) number is K850337.

When did CARDIAC CATHETERIZATION PACK receive FDA 510(k) clearance?

CARDIAC CATHETERIZATION PACK received FDA 510(k) clearance on 1985-02-25, under 510(k) number K850337.

Who is the listed applicant for CARDIAC CATHETERIZATION PACK?

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

What is the FDA product code for CARDIAC CATHETERIZATION PACK?

The FDA product code for CARDIAC CATHETERIZATION PACK is DRE.

Related Clinical Trials

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Other records listing Marwood Medical, 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.

K850340EYE PROCEDURE PACKK850338EMERGENCY ROOM PACKK850339SPECIAL PROCEDURES PACKK850341CARDIOVASCULAR SET UPK840620TPN/CVP DRESSING CHANGE KITK840619I.V. START KIT

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Related Devices (Code: DRE)

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.

K261310FlexTract Deflectable-Rotational Dilator Sheath SetMerit Medical Systems, Inc.K253616ProtekDilate Vascular Access KitSorin Group Italia S.R.L.K251325VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.K242229Micro Ace Gold Advanced Micro Access SystemMerit Medical Systems, Inc.K241720VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.K233647VersaCross Connect™ Transseptal DilatorBaylis Medical Company, 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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