Right Atrial Catheter Kits

FDA 510(k) K920331 · Akcess Medical Products, Inc.

Unknown

510(k) numberK920331

Submission

Device name
Right Atrial Catheter Kits
Applicant
Akcess Medical Products, Inc.
New Brunswick, NJ, US
Received
January 23, 1992
Decision date
April 22, 1992
Decision
Unknown (SESK)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
DQY – Catheter, Percutaneous
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1250
Specialty
Cardiovascular

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More from Abbott Medical

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K926374Silicone Catheter Repair KitsKOC · Traditional 10/07/1994SESK
K925819AKCESS0CATH KitLFJ · Traditional 08/02/1994SE
K925818Akcess-CathLFJ · Traditional 04/05/1994SE
K930630Right Atrial CatheterLJS · Traditional 02/07/1994SN
K931120Coaxial Acute CatheterLFJ · Traditional 01/14/1994SE
K920634Splittable Sheath Introducer SetLFJ · Traditional 01/14/1994SE
K914936Continuous Arteriovenous Hemofiltration Cath SetLFK · Traditional 04/23/1992SESK
K914826Akcess-Cath KitLFJ · Traditional 04/10/1992SESK
K915215Continuous Arteriovenous Hemofiltration Cath. KitsLFK · Traditional 03/27/1992SESK
K911333Right Atrial CathetersDQY · Traditional 09/23/1991SE

Questions and answers

When was Right Atrial Catheter Kits cleared by the FDA?

Right Atrial Catheter Kits (K920331) received a 510(k) decision of Unknown on April 22, 1992, 90 days after the submission was received.

What is the product code of K920331?

The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.