FDA device listing

AC1041MB-6,AC1045MB-6,AC1162MB-6,INTRODUCER CATHETER,POLYPROPYLENE DILATOR,Vascu Sheath

FDA device listing 1788121476 · MARTECH MEDICAL PRODUCTS

Key facts

Proprietary names AC1041MB-6,AC1045MB-6,AC1162MB-6,INTRODUCER CATHETER,POLYPROPYLENE DILATOR,Vascu Sheath
Owner/operator MARTECH MEDICAL PRODUCTS
Owner/operator number 2527072
Product codes DYB
Device names DYB - Introducer, Catheter
Device class Class II
Classification regulations (21 CFR) 870.1340
Review panels Cardiovascular
Registered establishments MARTECH MEDICAL PRODUCTS, MARTECH MEDICAL PRODUCTS S. DE RL. DE CV.
Establishment registrations 2527072, 3003915875
FEI numbers 2527072, 3003915875
Establishment operations Contract Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None listed Premarket submission listed

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device listings

Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.

Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database

Browse all FDA device listings