Product Code: DWM FDA class 2 21 CFR 870.5050

Apparatus, Suction, Patient Care

Cardiovascular

The Patient Care Suction Apparatus is a cardiovascular accessory device used to aspirate fluids, secretions, or blood from a patient's body cavities or surgical field, maintaining a clear and accessible operative or clinical environment. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DWM and it is regulated under 21 CFR 870.5050 within the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: DWM
Device Class: FDA class 2
Regulation Number: 870.5050
Medical Specialty: Cardiovascular
Review Panel: AN
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 19 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K212696	Aspira Pleural Drainage System	Mar 03, 2023	Substantially Equivalent	Merit Medical Systems, Inc.
K210509	Rocket Platinum Cured Cathter	Sep 09, 2021	Unknown	Rocket Medical Plc
K201404	Passio Pump Drainage System	Nov 20, 2020	Substantially Equivalent	Bearpac Medical
K190292	Passio Pump Drainage System	Jul 25, 2019	Substantially Equivalent	Bearpac Medical
K163321	Rocket Indwelling Pleural Catheter (IPC) Insertion Kit	Aug 17, 2017	Substantially Equivalent	Rocket Medical Plc
K160450	Pleurx Pleural Catheter System	Oct 31, 2016	Substantially Equivalent	Care Fusion
K141965	PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT	Jul 02, 2015	Substantially Equivalent	Care Fusion
K123033	ROCKET IPC INSERTION PACK, ROCKET IPC MINI INSERTION SET, ROCKET IPC DRESSING PACK AND BOTTLE SET, ROCKET IPC DRAINAGE B	Feb 01, 2013	Substantially Equivalent	Rocket Medical Plc
K121849	PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT, PLEURX CATHETER INSERTION STYLET, PLEURX INTEGRAL VALVED PEE	Oct 18, 2012	Substantially Equivalent	Care Fusion
K112831	PLEURX PLEURAL CATHETER SYSTEMS	Feb 16, 2012	Substantially Equivalent	Care Fusion
K110409	ASPIRA PLEURAL DRAINAGE SYSTEM	May 11, 2011	Substantially Equivalent	C.R. Bard, Inc.
K093307	ASEPT PLEURAL DRAINAGE SYSTEM	Nov 06, 2009	Substantially Equivalent	Pfm Medical, Inc.
K071095	ASPIRA PLEURAL DRAINAGE SYSTEM	May 18, 2007	Substantially Equivalent	Bard Access Systems, Inc.
K052436	PLEURX PLEURAL CATHETER KIT, MODEL 50-7000	Oct 06, 2005	Substantially Equivalent	Denver Biomedical, Inc.
K051084	DENVER PLEURX DRAINAGE KIT AND DENVER PLEURX VACUUM BOTTLE WITH DRAINAGE LINE	Jun 13, 2005	Substantially Equivalent	Denver Biomedicals, Inc.
K011831	MODIFICATION TO PLEURX PLEURAL CATHETER AND DRAINAGE KITS	Jun 28, 2001	Substantially Equivalent	Denver Biomedical, Inc.
K010642	PLEURX PLEURAL CATHETER AND DRAINAGE KITS	Mar 20, 2001	Substantially Equivalent	Denver Biomedicals, Inc.
K971753	DENVER PLEURX PLEURAL CATHETER KIT, CATALOG NO. 50-7000, DENVER PLEURX HOME DRAINAGE KIT, CATALOG NO. 50-7500	Jun 27, 1997	Unknown	Denver Biomaterials, Inc.
K803037	WILLIAM HARVEY VENTED MEDIASTINAL DRAIN	Feb 04, 1981	Substantially Equivalent	C.R. Bard, Inc.