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FDA 510(k)

RIGHT ATRIAL CATHETERS

K-Number: K911333 · 1991-09-23

ApplicantAkcess Medical Products, Inc.
Decision Date1991-09-23
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RIGHT ATRIAL CATHETERS is the device name listed in this FDA 510(k) record. The listed applicant is Akcess Medical Products, Inc.. It received FDA 510(k) clearance on 1991-09-23 under 510(k) number K911333. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RIGHT ATRIAL CATHETERS?

RIGHT ATRIAL CATHETERS is a medical device that received FDA 510(k) clearance on 1991-09-23. The listed applicant is Akcess Medical Products, Inc.. The 510(k) number is K911333.

When did RIGHT ATRIAL CATHETERS receive FDA 510(k) clearance?

RIGHT ATRIAL CATHETERS received FDA 510(k) clearance on 1991-09-23, under 510(k) number K911333.

Who is the listed applicant for RIGHT ATRIAL CATHETERS?

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

What is the FDA product code for RIGHT ATRIAL CATHETERS?

The FDA product code for RIGHT ATRIAL CATHETERS is DQY.

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Other records listing Akcess Medical Products, 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.

K926374SILICONE CATHETER REPAIR KITSK925819AKCESS0CATH KITK925818AKCESS-CATHK930630RIGHT ATRIAL CATHETERK931120COAXIAL ACUTE CATHETERK920634SPLITTABLE SHEATH INTRODUCER SET

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Related Devices (Code: DQY)

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.

K262817CrossFAST Integrated Microcatheter Advanced Delivery SystemVantis Vascular, Inc.K260559NHanceITIMDS Operation B.V.K262392APRO 35 Swift CatheterAlembic, LLCK262240SSPC NXT Delivery CatheterCenterPoint Systems, LLCK261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLCK261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterAbbott

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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