DILATOR, VESSEL & INTRODUCER, SHEATH— 510(k) K780126

Clearance details

Applicant

Argon Medical Corp.

Product code

Code DRE

Device class

Class 2

Regulation

21 CFR 870.1310

Advisory panel

Cardiovascular

Date received

1978-01-24

Decision date

1978-03-02

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Walker, MI, US

• K261310 — FlexTract Deflectable-Rotational Dilator Sheath Set2026-07-27
• K253616 — ProtekDilate Vascular Access Kit2025-12-19
• K251325 — VersaCross Connect Transseptal Dilator2025-05-29
• K242229 — Micro Ace Gold Advanced Micro Access System2025-01-15
• K241720 — VersaCross Connect Transseptal Dilator2024-07-12

• K904994 — CLOSED SYSTEM FLUSH SET1991-01-15
• K895511 — CATHETER BALLOON DILATOR PRESSURE GAUGE1990-02-28
• K894157 — OBTURATOR1989-09-28
• K891022 — INTRODUCER FOR PTCA GUIDING CATHETERS1989-05-19
• K884375 — TRANSLUMBAR AORTOGRAPHY NEEDLE CATHETER1989-01-11

Death

100

Injury

832

Malfunction

597

Other

3

Total

1,532

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-2705-2026 — One-Piece Introducer Tray, REF: 497455, 497434 cardiovascularClass I·Ongoing·Argon Medical Devices, Inc·20260601
• Z-2806-2020 — ClosureFast Micro Introducer Sheath Set, REF MIS-7F11; 7Fr/Ch (2.3mm)x11 cm. STERILE|EO; Rx ONLY - Product Usage: Introducer Products are stand-alone components, standard kits, or convenience kits built to user specifications. These products facilitate access to a vein or artery, allowing various catheters to be passed through for local or central diagnostic or therapeutic interventions. Indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.Class II·Terminated·Argon Medical Devices, Inc·20200619
• Z-1938-2020 — PAC Tray/5 Catheter Introducer Tray 8F, Model 497424, Rx Only, STERILE EO, UDI: 00886333214440 - Product Usage: The introducers are indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices. Curved tip Introducer allows for contralateral access to the iliac artery and selected vasculature. Case Label: PAC Tray/5 Catheter Introducer Tray 8F, QTY 10/Bx, Rx Only, STERILE EOClass II·Terminated·Argon Medical Devices, Inc·20200408
• Z-1029-2016 — ClosureFast Micro Introducer Sheath Set 7Fr/Ch(2.3mm) x 7 cm REF MIS-F707 and ClosureFast Introducer Sheath Set 7Fr/Ch(2.3mm) x 11 cm REF IS-7F11. Indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.Class II·Terminated·Argon Medical Devices, Inc·20160217

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K780126.