Amplatzer Vascular Plug
FDA 510(k) K031810 · Aga Medical Corp.
510(k) numberK031810
Submission
- Device name
- Amplatzer Vascular Plug
- Applicant
- Aga Medical Corp.
Plymouth, MN, US - Received
- June 12, 2003
- Decision date
- September 9, 2003
- 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 |
|---|---|---|
| K121611 | Amplatzer Torqvue FXDQY · Traditional | 08/23/2012SE |
| K113658 | Amplatzer Vascular Plug 4KRD · Traditional | 06/12/2012SE |
| K120120 | Amplatzer Torqvue 45X45 Delivery Sheath Amplatzer Torqvue LA1 Delivery Sheath Amplatzer…DQY · Special | 03/15/2012SE |
| K093476 | Amplatzer Torq Vue 2 Delivery Sheath Model 9-TV2-05F120, Model 9-TV2-06F120…DQY · Traditional | 02/05/2010SE |
| K091793 | Amplatzer Torqvue 3 Delivery Sheath, Model 9-TV3-08F104, 9-TV3-08F54DQY · Special | 07/09/2009SE |
| K083214 | Amplatzer Torqvue 45DEGREEX45DEGREE Delivery Sheath, Models 9-TV45X45-09F-100…DQY · Special | 05/12/2009SE |
| K080994 | Amplatzer Torqvue Exchange SystemDQY · Traditional | 05/16/2008SE |
| K080757 | Amplatzer Torqvue Low Profile Delivery SystemDQY · Special | 04/18/2008SE |
| K072313 | Amplatzer Torqvue Delivery SystemDQY · Traditional | 11/02/2007SE |
| K071699 | Amplatzer Vascular Plug II, Models AVP2-003, AVP2-018, AVP2-020, AVP2-022KRD · Special | 08/15/2007SE |
Questions and answers
When was Amplatzer Vascular Plug cleared by the FDA?
Amplatzer Vascular Plug (K031810) received a 510(k) decision of Substantially Equivalent on September 9, 2003, 89 days after the submission was received.
What is the product code of K031810?
The FDA product code is KRD – Device, Vascular, For Promoting Embolization, a Class II (moderate risk) device regulated under 21 CFR 870.3300.