Product code DOX— Clinical Toxicology

FDA has cleared 4 devices under product code DOX between 1983 and 2002, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20021 clearance
• 19951 clearance
• 19901 clearance
• 19831 clearance

• National-Standard Medical Products1 clearance
• Msi, Inc.1 clearance
• Boston Scientific Corp1 clearance
• Argon Medical Corp.1 clearance

• K014195 — KAYAK HYDROPHILIC GUIDE WIRESBoston Scientific Corp·2002-03-19
• K944226 — MSI PROCEDURE KITMsi, Inc.·1995-06-21
• K900822 — HYDRO-SIL(TM) COATED GUIDEWIRESNational-Standard Medical Products·1990-07-17
• K832030 — HEPARIN COATED STAINLESS STEEL/TEFLONArgon Medical Corp.·1983-09-29