CARDIOFLON, CARDIOXYL— 510(k) K060163

Clearance details

Applicant

Peters Surgical

Product code

Code GAT

Device class

Class 2

Regulation

21 CFR 878.5000

Advisory panel

General, Plastic Surgery

Date received

2006-01-23

Decision date

2006-10-11

Decision

Substantially Equivalent

Clearance type

Special

Location

Bobigny, FR

• K253910 — Stitch - Suture Wires and Tapes2026-08-22
• K261021 — EasyWhip Family2026-07-01
• K260775 — Polyethylene; Polyethylene Fusion; Polyethylene OrthoTape2026-05-06
• K254275 — HyperSuture All Green Extension Line2026-03-23
• K254188 — Meniscus Versaflex2026-02-19

• K233265 — Monotime and Optime R2024-10-11
• K232372 — Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME)2024-07-12
• K071281 — UNIRING - ANNULOPLASTY RING WITH SIZERS2007-08-03
• K060465 — PREMIO2007-01-17
• K062366 — OPTIME, SINUSORB PGA2006-10-02

Death

19

Injury

4,163

Malfunction

8,646

Other

2

Total

12,830

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-2675-2014 — The synthetic non-absorbable surgical sutures CARDIOXYL are composed of a polyester [poly(ethylene terephtalate)] braids, with or without PLEDGET of different sizes. CARDIOXYL braids are coated with polysiloxane. CARDIOXYL sutures are green dyed (D&C green # 6, CI 61565) and white (undyed). Some packs are composed of green and white braids to facilitate location during use. CARDIOXYL sutures comply with the requirements of the United States Pharmacopoeia (USP) and the European Pharmacopoeia (EP) for non-absorbable surgical sutures. Type of packaging: - Unit: Sutures are packed in a support card Onepak or in a pack under an external polyethylene/ paper peel pouch. - Box: 36 units for double armed (36 sutures), 24 units for ligatures (24 reels), 12 packs for double armed (5 Green/5 White) (120 sutures).Class II·Terminated·Peters Surgical·20140625
• Z-2676-2014 — The synthetic non-absorbable surgical sutures CARDIOFLON Evolution are composed of polyester [poly(ethylene terephtalate)] braids, coated, with or without PLEDGETS of different sizes. CARDIOFLON Evolution sutures are green dyed (D&C green # 6, CI 61565) and white (undyed). Some packs are composed of green and white braids to facilitate location during use. CARDIOFLON Evolution sutures comply with the requirements of the United States Pharmacopoeia (USP) and the European Pharmacopoeia (EP) for non-absorbable surgical sutures, except for some diameters. Type of packaging: - Unit: Sutures are packed in a support card Onepak or in a pack under an external polyethylene/ paper peel pouch. - Box: 36 units for single or double armed (36 sutures), 24 units of ligatures (24 reels), 12 packs for double armed (10 Green or 5 Green/5 White) (120 sutures).Class II·Terminated·Peters Surgical·20140625

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K060163.