Atlas FDA

Rocket Indwelling Pleural Catheter (IPC) Insertion Kit

FDA 510(k) clearance K163321 · decided 2017-08-17

Clearance details

K-number
K163321
Device name
Rocket Indwelling Pleural Catheter (IPC) Insertion Kit
Applicant
Rocket Medical Plc
Decision
Substantially Equivalent
Date received
2016-11-25
Decision date
2017-08-17
Days to decision
265 days
Clearance type
Traditional
Product code
DWM
Device class
2
Regulation number
870.5050
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Washington, GB
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Rocket Medical Plc

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Aspira Pleural Drainage System (K212696)Merit Medical Systems, Inc.2023-03-03
Rocket Platinum Cured Cathter (K210509)Rocket Medical Plc2021-09-09
Passio Pump Drainage System (K201404)Bearpac Medical2020-11-20
Passio Pump Drainage System (K190292)Bearpac Medical2019-07-25
Pleurx Pleural Catheter System (K160450)Care Fusion2016-10-31
PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT (K141965)Care Fusion2015-07-02
ROCKET IPC INSERTION PACK, ROCKET IPC MINI INSERTION SET, ROCKET IPC DRESSING PACK AND BOTTLE SET, ROCKET IPC DRAINAGE B (K123033)Rocket Medical Plc2013-02-01
PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT, PLEURX CATHETER INSERTION STYLET, PLEURX INTEGRAL VALVED PEE (K121849)Care Fusion2012-10-18
PLEURX PLEURAL CATHETER SYSTEMS (K112831)Care Fusion2012-02-16
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.