Product code DWQ— Cardiovascular

FDA has cleared 8 devices under product code DWQ between 1981 and 2022, filed by 7 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.

• 20221 clearance
• 20041 clearance
• 20031 clearance
• 19912 clearances
• 19901 clearance
• 19871 clearance
• 19811 clearance

• Smith & Nephew, Inc.2 clearances
• Uresil Corp.1 clearance
• Solco Basle, Inc.1 clearance
• Pilling Co.1 clearance
• LeMaitre Vascular, Inc.1 clearance
• Atrium Medical Corp.1 clearance
• Aesculap Instruments Corp.1 clearance

• K212894 — PhasTIPPLeMaitre Vascular, Inc.·2022-03-31
• K041453 — SMITH & NEPHEW TUMESCENT CATHETER INVERSION SYSTEM, MODEL 7210023Smith & Nephew, Inc.·2004-07-22
• K032387 — TRIVEX SYSTEMSmith & Nephew, Inc.·2003-10-29
• K905528 — URESIL VALVE CUTTERUresil Corp.·1991-04-18
• K904507 — PILLING BRUSH VALVULOTOMEPilling Co.·1991-03-01
• K885046 — INSITUCAT VALVE STRIPPERAesculap Instruments Corp.·1990-02-28
• K872157 — HALL VEIN STRIPPERSolco Basle, Inc.·1987-07-07
• K811910 — VEIN-TRAP TMAtrium Medical Corp.·1981-07-20