ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer Catheter
FDA 510(k) clearance K220781 · decided 2023-05-05
Clearance details
- K-number
- K220781
- Device name
- ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer Catheter
- Applicant
- Allwin Medical Devices, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-03-17
- Decision date
- 2023-05-05
- Days to decision
- 414 days
- Clearance type
- Traditional
- Product code
- EZN
- Device class
- 2
- Regulation number
- 876.5470
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Anaheim, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.