NAJ · Agents, Embolic, For Treatment Of Uterine Fibroids
Cardiovascular · 21 CFR 870.3300 · Class 2
Overview
| Product Code | NAJ |
|---|---|
| Device Name | Agents, Embolic, For Treatment Of Uterine Fibroids |
| Regulation | 21 CFR 870.3300 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| Implant | Yes |
Identification
A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.
Classification Rationale
Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 870.1(e).
Special Controls
*Classification.* Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 870.1(e).
Cleared Devices (8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K233813 | Bearing nsPVA Express | Merit Medical Systems, Inc. | Dec 21, 2023 | SESE |
| K173871 | CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres | Suzhou Hengrui Callisyn Biomedical Co., Ltd. | Sep 17, 2018 | SESE |
| K133447 | EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES | Celonova Biosciences, Inc. | Feb 24, 2014 | SESE |
| K130259 | BEARING NSPVA EMBOLIZATION PARTICLES | Merit Medical Systems, Inc. | Jun 7, 2013 | SESE |
| K100663 | CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600221, M0017600321 | Boston Scientific Corporation | Apr 16, 2010 | SESE |
| K081768 | COOK INCORPORATED POLYVINYL ALCOHOL FOAM EMBOLIZATION PARTICLES | Cook Incorporated | Dec 23, 2008 | SESE |
| K030966 | CONTOUR EMBOLI PVA AND FASTRACKER-325 INFUSION CATHETER | Boston Scientific Corp | Sep 23, 2003 | SESE |
| K021397 | EMBOSPHERE MICROSPHERES AND EMBOGOLD MICROSPHERES FOR USE IN UTERINE FIBROID EMBOLIZATION | Biosphere Medical, Inc. | Nov 22, 2002 | SESE |
Top Applicants
- Merit Medical Systems, Inc. — 2 clearances
- Suzhou Hengrui Callisyn Biomedical Co., Ltd. — 1 clearance
- Cook Incorporated — 1 clearance
- Celonova Biosciences, Inc. — 1 clearance
- Boston Scientific Corporation — 1 clearance
