Chrysalis Intelligence · Sponsors · Terumo Medical Corporation

Terumo Medical Corporation

Elkton, MD, US · 3 510(k) clearances · 23 PMAs

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Total clearances
3
2020-01-06 → 2023-07-27
Last 12 months
0
Product codes
3
Most recent
2023-07-27
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
DQY — — — 1 2023-07-27
DXC Clamp, Vascular Class II Cardiovascular 1 2021-12-20
DYB Introducer, Catheter Class II Cardiovascular 1 2020-01-06
Class III

PMA approvals (23)

Total PMA records
23
Originals + supplements
Distinct product codes
3
First decision
2020-12-09
Most recent
2026-08-04
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2026-08-04 P930038-S107 Angio Seal VIP Vascular Closure Device 135 Review Track For 30-Day Notice MGB — —
2026-07-16 P140002-S032 MISAGO(TM) RX Self-expanding Peripheral Stent Panel Track NIO Stent, Iliac Unknown
2026-02-13 P140002-S033 MISAGO® RX Self-expanding Peripheral Stent 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2025-12-12 P140002-S031 MISAGO® RX Self-expanding Peripheral Stent Real-Time Process NIP Stent, Superficial Femoral Artery Unknown
2025-09-12 P140002-S030 MISAGO® RX Self-expanding Peripheral Stent 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2025-08-07 P930038-S106 Angio-Seal Vascular Closure Device 30-Day Notice MGB — —
2025-08-05 P140002-S029 MISAGO® RX Self-expanding Peripheral Stent; R2P Misago RX Self-expanding Peripheral Stent System 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2024-11-26 P930038-S105 ANGIO-SEAL VIP Vascular Closure Device 30-Day Notice MGB — —
2024-11-14 P140002-S028 MISAGO RX Self-expanding Peripheral Stent System, R2P MISAGO RX Self-expanding Peripheral Stent System 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2024-11-08 P930038-S103 Angio-Seal Vascular Closure Device Real-Time Process MGB — —
2024-08-23 P930038-S102 Angio-Seal VIP Vascular Closure Devices 30-Day Notice MGB — —
2023-11-21 P140002-S027 MISAGO® RX Self-expanding Peripheral Stent 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2023-10-11 P930038-S101 ANGIO-SEAL VIP Vascular Closure Device 30-Day Notice MGB — —
2023-09-26 P210017 Cross-Seal Suture-Mediated Vascular Closure Device System Original MGB — —
2023-09-21 P140002-S026 MISAGO® RX Self-expanding Peripheral Stent 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2023-04-13 P140002-S024 MISAGO RX SELF-EXPANDING PERIPHERAL STENT SYSTEM, R2P MISAGO RX SELF-EXPANDING PERIPHERAL STENT SYSTEM 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2023-04-07 P140002-S025 MISAGO RX SELF-EXPANDING PERIPHERAL STENT SYSTEM, R2P MISAGO RX SELF-EXPANDING PERIPHERAL STENT SYSTEM 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2023-02-09 P930038-S099 ANGIO-SEAL VIP Vascular Closure Device Normal 180 Day Track No User Fee MGB — —
2022-11-18 P140002-S023 MISAGO® RX Self-expanding Peripheral Stent 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2022-10-21 P140002-S022 MISAGO® RX Self-expanding Peripheral Stent 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2022-08-26 P930038-S100 ANGIO-SEAL VIP Vascular Closure Device 30-Day Notice MGB — —
2021-06-09 P140002-S021 MISAGO RX Self-expanding Peripheral Stent System 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2020-12-09 P930038-S098 Angio Seal Vascular Closure Device 30-Day Notice MGB — —
Filings

All 510(k) clearances (3)

Date K-number Device Code Class Specialty
2023-07-27 K231044 R2P Navicross DQY — —
2021-12-20 K213531 TR BAND Radial Compression Device DXC Class II Cardiovascular
2020-01-06 K193125 R2P Destination Slender Guiding Sheath DYB Class II Cardiovascular
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence