Product code DSS— Cardiovascular

FDA has cleared 8 devices under product code DSS between 1977 and 1999, filed by 8 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.

• 19991 clearance
• 19961 clearance
• 19923 clearances
• 19901 clearance
• 19881 clearance
• 19771 clearance

• Research Medical, Inc.1 clearance
• Puritas Health Care, Inc.1 clearance
• Horizon Surgical, Inc.1 clearance
• Heartport, Inc.1 clearance
• Catheter Research C/O Burditt, Bowles & Radzius1 clearance
• Axiom Medical, Inc.1 clearance
• Applied Vascular Devices, Inc.1 clearance
• Applied Medical Resources1 clearance

• K983744 — MCAS (MODULAR CLIP APPLIER SYSTEM)Applied Medical Resources·1999-01-21
• K961333 — HEARTPORT MULTIFIRE CLIP APPLIERHeartport, Inc.·1996-11-15
• K920104 — IDENTI LOOPS DEGANIA SILICONEPuritas Health Care, Inc.·1992-04-20
• K920676 — RMI SOFCLAMPResearch Medical, Inc.·1992-04-15
• K914523 — CRI VESSEL OCCLUSIN SYSTEM/CRI OCCLUSION COILCatheter Research C/O Burditt, Bowles & Radzius·1992-01-10
• K901303 — HORIZON SURGICAL LIGATING AND MARKING CLIPHorizon Surgical, Inc.·1990-06-05
• K883909 — SURGICAL SPRING CLIPSApplied Vascular Devices, Inc.·1988-12-27
• K771021 — AUTO-CLIPAxiom Medical, Inc.·1977-06-14