Modified Thoracentesis Catheter

FDA 510(k) K811437 · Blair Medical Products

Substantially Equivalent

510(k) numberK811437

Submission

Device name
Modified Thoracentesis Catheter
Applicant
Blair Medical Products
Mchenry, IL, US
Received
May 22, 1981
Decision date
August 13, 1981
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KDQ – Bottle, Collection, Vacuum
Device class
Class II (moderate risk)
Regulation
21 CFR 880.6740
Specialty
General Hospital

Other 510(k)s with product code KDQ

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K081718Express Chest DrainKDQ · Special Atrium Medical Corp.07/25/2008SE
K062302Millicore AB Digivent Chest Drainage SystemKDQ · Traditional Millicore AB10/06/2006SE
K043582Ocean Chest DrainKDQ · Special Atrium Medical Corp.01/21/2005SE
K984496Atrium Medical Corporation Express Chest DrainKDQ · Traditional Atrium Medical Corp.05/05/1999SE
K962856Pleur-Evac Sahara Adult/Pediatric Chest Drainage System Model S-1100, S-1200, 2-2100…KDQ · Traditional Deknatel, Inc.08/28/1996SE
K961287Rocket Pleuraseal II Chest Drainage SystemKDQ · Traditional Rocket Medical Plc07/26/1996SE
K962168Mucus Specimen TrapKDQ · Traditional Sage Products, Inc.07/22/1996SE
K950677Atrium Dry Suction Control Water Seal Chest DrainKDQ · Traditional Atrium Medical Corp.04/13/1995SE
K941818PM9000 Vac TrapKDQ · Traditional Precision Medical, Inc.12/12/1994SE
K932327Thora-Klex 350 ML Pediatric Chest Drainage SystemKDQ · Traditional Davol, Inc.07/13/1993SE

Questions and answers

When was Modified Thoracentesis Catheter cleared by the FDA?

Modified Thoracentesis Catheter (K811437) received a 510(k) decision of Substantially Equivalent on August 13, 1981, 83 days after the submission was received.

What is the product code of K811437?

The FDA product code is KDQ – Bottle, Collection, Vacuum, a Class II (moderate risk) device regulated under 21 CFR 880.6740.