Aspira Pleural Drainage System
FDA 510(k) K071095 · Bard Access Systems, Inc.
510(k) numberK071095
Submission
- Device name
- Aspira Pleural Drainage System
- Applicant
- Bard Access Systems, Inc.
Salt Lake City, UT, US - Received
- April 18, 2007
- Decision date
- May 18, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- DWM – Apparatus, Suction, Patient Care
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5050
- Specialty
- Cardiovascular
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K212696 | Aspira Pleural Drainage SystemDWM · Traditional | Merit Medical Systems, Inc. | 03/03/2023SE |
| K210509 | Rocket Platinum Cured CathterDWM · Traditional | Rocket Medical Plc | 09/09/2021SESK |
| K201404 | Passio Pump Drainage SystemDWM · Traditional | Bearpac Medical | 11/20/2020SE |
| K190292 | Passio Pump Drainage SystemDWM · Traditional | Bearpac Medical | 07/25/2019SE |
| K163321 | Rocket Indwelling Pleural Catheter (IPC) Insertion KitDWM · Traditional | Rocket Medical Plc | 08/17/2017SE |
| K160450 | Pleurx Pleural Catheter SystemDWM · Traditional | Care Fusion | 10/31/2016SE |
| K141965 | Pleurx Pleural Catheter System, Pleurx Catheter Access KitDWM · Traditional | Care Fusion | 07/02/2015SE |
| K123033 | Rocket Ipc Insertion Pack, Rocket Ipc Mini Insertion Set, Rocket Ipc Dressing Pack and…DWM · Traditional | Rocket Medical Plc | 02/01/2013SE |
| K121849 | Pleurx Pleural Catheter System, Pleurx Catheter Access Kit, Pleurx Catheter Insertion…DWM · Traditional | Care Fusion | 10/18/2012SE |
| K112831 | Pleurx Pleural Catheter SystemsDWM · Traditional | Care Fusion | 02/16/2012SE |
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Questions and answers
When was Aspira Pleural Drainage System cleared by the FDA?
Aspira Pleural Drainage System (K071095) received a 510(k) decision of Substantially Equivalent on May 18, 2007, 30 days after the submission was received.
What is the product code of K071095?
The FDA product code is DWM – Apparatus, Suction, Patient Care, a Class II (moderate risk) device regulated under 21 CFR 870.5050.