GUIDEWIRES— 510(k) K042264
Substantially EquivalentRocket Medical Plc
FDA 510(k) clearance K042264 for GUIDEWIRES, Substantially Equivalent on 2004-11-24. Applicant: Rocket Medical Plc. Device class: 2.
Clearance details
- Applicant
- Rocket Medical Plc
- Product code
- Code DQX
- Device class
- Class 2
- Regulation
- 21 CFR 870.1330
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Washington, Tyne & Wear, GB
Recent devices under product code DQX
view allMore clearances from Rocket Medical Plc
view all- K210509 — Rocket Platinum Cured Cathter
- K163321 — Rocket Indwelling Pleural Catheter (IPC) Insertion Kit
- 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
Adverse events under product code DQX
product code DQX- Death
- 298
- Injury
- 4,385
- Malfunction
- 7,203
- Other
- 5
- Total
- 11,891
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.