Product code QVG
- Device name
- Embolization Agent, Vascular
- Medical specialty
- Unknown
- Device class
- 3
- Review panel
- CV
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- For occluding peripheral vessels
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P220020S008 | Lava Liquid Embolic System (Lava LES) | Sirtex Medical, Inc. | 2026-07-09 |
| P250003S005 | Embrace Hydrogel Embolic System (HES) | Instylla, Inc. | 2026-04-02 |
| P250003S006 | Embrace Hydrogel Embolic System (HES) | Instylla, Inc. | 2026-04-01 |
| P250003S004 | Embrace™ Hydrogel Embolic System (HES) | Instylla, Inc. | 2026-02-12 |
| P250003S003 | Embrace™ Hydrogel Embolic System | Instylla, Inc. | 2026-02-04 |
| P250003S002 | Embrace™ Hydrogel Embolic System (HES) | Instylla, Inc. | 2025-12-17 |
| P250003S001 | Embrace(TM) Hydrogel Embolic System | Instylla, Inc. | 2025-11-25 |
| P220020S005 | Lava Liquid Embolic System (Lava LES) and Lava Mixing Kit | Sirtex Medical, Inc. | 2025-09-03 |
| P250003 | Embrace(TM) Hydrogel Embolic System | Instylla, Inc. | 2025-08-05 |
| P220020S007 | Lava Liquid Embolic System (Lava LES) and Lava Mixing Kit | Sirtex Medical, Inc. | 2025-08-05 |
| P220020S006 | Lava Liquid Embolic System (Lava LES) | Sirtex Medical, Inc. | 2025-06-02 |
| P220020S004 | Lava Liquid Embolic System (Lava LES) and Lava Mixing Kit | Sirtex Medical, Inc. | 2025-03-20 |
| P220020S003 | Lava Liquid Embolic System (Lava LES) | Sirtex Medical, Inc. | 2024-09-24 |
| P220020S002 | Lava Liquid Embolic System (Lava LES) | Sirtex Medical, Inc. | 2023-11-07 |
| P220020S001 | LAVA® Liquid Embolic System (LAVA LES) | Sirtex Medical, Inc. | 2023-10-26 |
| P220020 | Lava Liquid Embolic System (Lava LES) and Lava Mixing Kit | Sirtex Medical, Inc. | 2023-04-04 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00812013030215 | Embrace Hydrogel Embolic System (HES) | Instylla Inc. | 2025-12-01 |
| 00850055697003 | LAVA-18, 2 mL | Sirtex Medical Inc. | 2023-10-23 |
| 00850055697010 | LAVA-34, 2 mL | Sirtex Medical Inc. | 2023-10-23 |
| 00850055697027 | LAVA-18, 6 mL | Sirtex Medical Inc. | 2023-10-23 |
| 00850055697034 | LAVA-34, 6 mL | Sirtex Medical Inc. | 2023-10-23 |
| 00850055697041 | LAVA Mixing Kit, 2 mL | Sirtex Medical Inc. | 2023-10-23 |
| 00850055697058 | LAVA Mixing Kit, 6 mL | Sirtex Medical Inc. | 2023-10-23 |