ROCKET IPC INSERTION PACK, ROCKET IPC MINI INSERTION SET, ROCKET IPC DRESSING PACK AND BOTTLE SET, ROCKET IPC DRAINAGE B
FDA 510(k) clearance K123033 · decided 2013-02-01
Clearance details
- K-number
- K123033
- Device name
- ROCKET IPC INSERTION PACK, ROCKET IPC MINI INSERTION SET, ROCKET IPC DRESSING PACK AND BOTTLE SET, ROCKET IPC DRAINAGE B
- Applicant
- Rocket Medical Plc
- Decision
- Substantially Equivalent
- Date received
- 2012-09-28
- Decision date
- 2013-02-01
- Days to decision
- 126 days
- Clearance type
- Traditional
- Product code
- DWM
- Device class
- 2
- Regulation number
- 870.5050
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Washington, Tyne & Wear, GB
- Third-party review
- No
- Expedited review
- No
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| Rocket Platinum Cured Cathter (K210509) | Rocket Medical Plc | 2021-09-09 |
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| Passio Pump Drainage System (K190292) | Bearpac Medical | 2019-07-25 |
| Rocket Indwelling Pleural Catheter (IPC) Insertion Kit (K163321) | Rocket Medical Plc | 2017-08-17 |
| Pleurx Pleural Catheter System (K160450) | Care Fusion | 2016-10-31 |
| PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT (K141965) | Care Fusion | 2015-07-02 |
| PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT, PLEURX CATHETER INSERTION STYLET, PLEURX INTEGRAL VALVED PEE (K121849) | Care Fusion | 2012-10-18 |
| PLEURX PLEURAL CATHETER SYSTEMS (K112831) | Care Fusion | 2012-02-16 |
| ASPIRA PLEURAL DRAINAGE SYSTEM (K110409) | C.R. Bard, Inc. | 2011-05-11 |
| ASEPT PLEURAL DRAINAGE SYSTEM (K093307) | Pfm Medical, Inc. | 2009-11-06 |
| ASPIRA PLEURAL DRAINAGE SYSTEM (K071095) | Bard Access Systems, Inc. | 2007-05-18 |
Recalls involving this device
No recalls on record reference this clearance.