Chrysalis Intelligence · Sponsors · Goodman Co., Ltd.

Goodman Co., Ltd.

Nagoya, JP · 2 510(k) clearances · 5 PMAs

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Total clearances
2
2024-03-28 → 2025-04-22
Last 12 months
0
Product codes
1
Most recent
2025-04-22
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
PNO Catheter, Percutaneous, Cutting/Scoring Class II Cardiovascular 2 2025-04-22
Class III

PMA approvals (5)

Total PMA records
5
Originals + supplements
Distinct product codes
1
First decision
2024-06-06
Most recent
2026-07-22
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2026-07-22 P230026-S005 Lacrosse NSE ALPHA Coronary Dilatation Catheter 30-Day Notice NWX Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring Unknown
2026-07-22 P230026-S004 Lacrosse NSE ALPHA Coronary Dilatation Catheter 30-Day Notice NWX Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring Unknown
2026-07-22 P230026-S003 Lacrosse NSE ALPHA Coronary Dilatation Catheter 30-Day Notice NWX Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring Unknown
2024-08-02 P230026-S001 Lacrosse NSE ALPHA Coronary Dilatation Catheter Normal 180 Day Track No User Fee NWX Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring Unknown
2024-06-06 P230026 Lacrosse NSE ALPHA Coronary Dilatation Catheter Original NWX Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring Unknown
Filings

All 510(k) clearances (2)

Date K-number Device Code Class Specialty
2025-04-22 K243944 Aperta NSE PTA Balloon Dilatation Catheter PNO Class II Cardiovascular
2024-03-28 K232013 Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040, AW18-09040040/AA18-09040040, AW18-14540040, AW18-05050040/AA18-05050040, AW18-09050040/AA18-09050040, AW18-14550040, AW18-05060040/AA18-05060040, AW18-09060040/AA18-09060040, AW18-14560040 AW18-05070040/AA18-05070040, AW18-09070040/AA18-09070040, AW18-14570040, AW18-05080040/AA18-05080040, AW18-09080040/AA18-09080040, AW18-14580040) PNO Class II Cardiovascular
Data source: openFDA · Generated 2026-08-04 09:33 · Last ingest 2026-08-04T13:32:59.017994 · Pipeline: Chrysalis Intelligence