FDA 510(k)
FDA class 2
Unknown
🇬🇧 United Kingdom
Rocket Platinum Cured Cathter
K Number: K210509
·
Decision Sep 9, 2021
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
18
Applicant Total
19
Review Days
199
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Basic Information
- Device Name
- Rocket Platinum Cured Cathter
- K Number
- K210509
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5050
- Medical Specialty
- Cardiovascular
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Rocket Medical Plc
- Date Received
- February 22, 2021
- Decision Date
- September 9, 2021
- Product Code
- DWM
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DWM | Apparatus, Suction, Patient Care | FDA class 2 | Cardiovascular |
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Other Clearances by Rocket Medical Plc
| K Number | Device Name | ||
|---|---|---|---|
| K163321 | Rocket Indwelling Pleural Catheter (IPC) Insertion Kit | Aug 17, 2017 | Substantially Equivalent |
| K162457 | Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit | Nov 14, 2016 | Unknown |
| K152105 | Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set | Mar 29, 2016 | Unknown |
| K123033 | ROCKET IPC INSERTION PACK, ROCKET IPC MINI INSERTION SET, ROCKET IPC DRESSING PACK AND BOTTLE SET, ROCKET IPC DRAINAGE B | Feb 1, 2013 | Substantially Equivalent |
| K052365 | CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGE | Oct 17, 2005 | Substantially Equivalent |
| K042264 | GUIDEWIRES | Nov 24, 2004 | Substantially Equivalent |
| K040189 | ENDOMETRIAL SAMPLING SYRINGE | Oct 4, 2004 | Substantially Equivalent |
| K032015 | EMBRYON ULTRASOUND NEEDLE GUIDE | Aug 8, 2003 | Substantially Equivalent |
| K000205 | EMBRYON SINGLE AND DOUBLE LUMEN NEEDLES | Apr 19, 2000 | Substantially Equivalent |
| K000340 | HYSTALOG HSG CATHETER | Apr 19, 2000 | Substantially Equivalent |