HydroPearl Microspheres— 510(k) K192684
Substantially EquivalentMicroVention, Inc.
FDA 510(k) clearance K192684 for HydroPearl Microspheres, Substantially Equivalent on 2020-01-22. Applicant: MicroVention, Inc.. Device class: 2.
Clearance details
- Applicant
- MicroVention, Inc.
- Product code
- Code NOY
- Device class
- Class 2
- Regulation
- 21 CFR 876.5550
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Aliso Viejo, CA, US
Recent devices under product code NOY
view all- K203276 — Bead Block (100 - 300µm, 1ml), Bead Block (300 - 500µm, 1ml), Bead Block (500 - 700µm, 1ml), Bead Block (700 - 900µm, 1ml), Bead Block (900 - 1200µm, 1ml), Bead Block (100 - 300µm, 2ml), Bead Block (300 - 500µm, 2ml), Bead Block (500 - 700µm, 2ml), Bead Block (700 - 900µm, 2ml), Bead Block (900 - 1200µm, 2ml)
- K180102 — Embozene Color-Advanced Microspheres
- DEN160040 — Embosphere Microspheres
More clearances from MicroVention, Inc.
view all- K232542 — Wedge XL Delivery Catheter
- K230775 — SOFIA EX Intracranial Support Catheter
- K222694 — EmPro EPS (EP4514C-190, EP6514C-190); Nanoparasol EPS (PNP4514C-190,PNP6514C-190)
- K222115 — ISAAC Neurovascular Navigation Catheter
- K223050 — AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060)
Recalls naming K192684
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K192684.
Data sourced from openFDA. This site is unofficial and independent of the FDA.