510(k) K121849
- Device
- PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT, PLEURX CATHETER INSERTION STYLET, PLEURX INTEGRAL VALVED PEE
- Applicant
- CAREFUSION
- 510(k) number
- K121849
- Product code
- DWM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-10-18
- Date received
- 2012-06-25
- Regulation
- 870.5050
- Classification name
- Apparatus, Suction, Patient Care
- Medical specialty
- Cardiovascular
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOY GREIDANUS
- Address
- 1500 Waukegan Rd. Waukegan IL US 60085 60085
FDA Registration Numbers#
- 3010155661
- 3000268902
- 3013666218
- 3014437893
- 3017210488
- 3010308146
- 3015309643
- 3006950086
- 3011642792
- 3033589330
- 2020394
- 3011534620
- 3010419931
- 1721676
- 3001124136
- 3015715211
- 1721504
- 9617592
- 1625685
- 1724474
- 2030624
- 3015225571
- 3006082230
- 1018233
- 3030626857
- 3012536737
- 9610632
- 9680904
- 1423507
Source Documents#
Other 510(k) Records For Product Code DWM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K212696 | Aspira Pleural Drainage System | Merit Medical Systems, Inc. | 2023-03-03 |
| K210509 | Rocket Platinum Cured Cathter | Rocket Medical Plc | 2021-09-09 |
| K201404 | Passio Pump Drainage System | Bearpac Medical | 2020-11-20 |
| K190292 | Passio Pump Drainage System | Bearpac Medical | 2019-07-25 |
| K163321 | Rocket Indwelling Pleural Catheter (IPC) Insertion Kit | Rocket Medical Plc | 2017-08-17 |
| K160450 | Pleurx Pleural Catheter System | Care Fusion | 2016-10-31 |
| K141965 | PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT | Care Fusion | 2015-07-02 |
| K123033 | ROCKET IPC INSERTION PACK, ROCKET IPC MINI INSERTION SET, ROCKET IPC DRESSING PACK AND BOTTLE SET, ROCKET IPC DRAINAGE B | Rocket Medical Plc | 2013-02-01 |
| K112831 | PLEURX PLEURAL CATHETER SYSTEMS | Care Fusion | 2012-02-16 |
| K110409 | ASPIRA PLEURAL DRAINAGE SYSTEM | C.R. Bard, Inc. | 2011-05-11 |
| K093307 | ASEPT PLEURAL DRAINAGE SYSTEM | Pfm Medical, Inc. | 2009-11-06 |
| K071095 | ASPIRA PLEURAL DRAINAGE SYSTEM | Bard Access Systems, Inc. | 2007-05-18 |
| K052436 | PLEURX PLEURAL CATHETER KIT, MODEL 50-7000 | Denver Biomedical, Inc. | 2005-10-06 |
| K051084 | DENVER PLEURX DRAINAGE KIT AND DENVER PLEURX VACUUM BOTTLE WITH DRAINAGE LINE | Denver Biomedicals, Inc. | 2005-06-13 |
| K011831 | MODIFICATION TO PLEURX PLEURAL CATHETER AND DRAINAGE KITS | Denver Biomedical, Inc. | 2001-06-28 |
Legacy Summary#
summary
FDA Review#
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