Pva Plus Vial Pva Foam Embolization Particles, Pva Plus Convenience Kit Pva Foam Embolization Particles
FDA 510(k) K073544 · Rj Medical, Inc.
510(k) numberK073544
Submission
- Device name
- Pva Plus Vial Pva Foam Embolization Particles, Pva Plus Convenience Kit Pva Foam Embolization Particles
- Applicant
- Rj Medical, Inc.
El Dorado Hills, CA, US - Received
- December 18, 2007
- Decision date
- March 5, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KRD – Device, Vascular, For Promoting Embolization
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3300
- Specialty
- Cardiovascular
- Implant
- Yes
Other 510(k)s with product code KRD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252812 | UniPearls® Embolic MicrospheresKRD · Traditional | Suzhou Haowei Medical Technology Co., Ltd. | 07/31/2026SE |
| K261488 | OBSIDIO Conformable EmbolicKRD · Traditional | Boston Scientific Corporation | 07/24/2026SE |
| K261866 | Concerto Versa Detachable CoilKRD · Special | Medtronic, Inc. | 06/24/2026SE |
| K260635 | HARBOR Occlusion DeviceKRD · Traditional | Nuvascular, Inc. | 06/12/2026SE |
| K260508 | LOBO Vascular Occlusion SystemKRD · Traditional | Okami Medical, Inc. | 04/10/2026SE |
| K253511 | Concerto Versa Detachable CoilKRD · Traditional | Medtronic, Inc. | 01/14/2026SE |
| K253677 | Tembo Embolic SystemKRD · Special | Instylla, Inc. | 12/15/2025SE |
| K253376 | OBSIDIO Conformable Embolic (M0013972101010)KRD · Special | Boston Scientific Corporation | 10/30/2025SE |
| K250209 | Polyvinyl Alcohol Embolic MicrospheresKRD · Traditional | Canyon Medical, Inc. | 09/23/2025SE |
| K250133 | HARBOR Occlusion DeviceKRD · Traditional | Nuvascular, Inc. | 07/09/2025SE |
More from Nuvascular, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K073419 | Pva Plus Vial Pva Foam Embolization Particles, Pva Plus Convenience Kit Pva Embolization…HCG · Traditional | 02/14/2008SE |
Questions and answers
When was Pva Plus Vial Pva Foam Embolization Particles, Pva Plus Convenience Kit Pva Foam Embolization Particles cleared by the FDA?
Pva Plus Vial Pva Foam Embolization Particles, Pva Plus Convenience Kit Pva Foam Embolization Particles (K073544) received a 510(k) decision of Substantially Equivalent on March 5, 2008, 78 days after the submission was received.
What is the product code of K073544?
The FDA product code is KRD – Device, Vascular, For Promoting Embolization, a Class II (moderate risk) device regulated under 21 CFR 870.3300.