Rocket Indwelling Pleural Catheter (IPC) Insertion Kit— 510(k) K163321
Substantially EquivalentRocket Medical Plc
FDA 510(k) clearance K163321 for Rocket Indwelling Pleural Catheter (IPC) Insertion Kit, Substantially Equivalent on 2017-08-17. Applicant: Rocket Medical Plc. Device class: 2.
Clearance details
- Applicant
- Rocket Medical Plc
- Product code
- Code DWM
- Device class
- Class 2
- Regulation
- 21 CFR 870.5050
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Washington, GB
Recent devices under product code DWM
view allMore clearances from Rocket Medical Plc
view all- K162457 — Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit
- K152105 — Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set
- K123033 — ROCKET IPC INSERTION PACK, ROCKET IPC MINI INSERTION SET, ROCKET IPC DRESSING PACK AND BOTTLE SET, ROCKET IPC DRAINAGE B
- K052365 — CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGE
- K042264 — GUIDEWIRES
Adverse events under product code DWM
product code DWM- Death
- 8
- Total
- 8
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.