510(k) Report

Devices descending from K001440

23 later devices reach Nextstitch Cardiovascular Valve Suture through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153076silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX…Teleflexmedical, Inc.20164—
+1K060165Axyaflex Polyester SutureAxya Medical, Inc.200611—
+1K022410Saph-Loop Ligating LoopGenzyme Biosurgery20025—
+2K192490Tevdek II, Silky II Polydek, 'Cottony' II, NextStitchTeleflex Medical20201—
+2K193530Deklene MAXXTeleflex Medical20200—
+2K162396SILK Surgical SutureTeleflexmedical, Inc.20160—
+2K090385Lariat II Suture Delivery DeviceSentreheart, Inc.20092—
+2K080684WG-Surgical Sutures with NeedleFoosin Medical Supplies, Inc.20089—
+2K073096Anchorage Closure DeviceEpitek, Inc.20080—
+2K063194Tufflex Polyester SutureAxya Medical, Inc.20060—
+2K060721Lariat Loop ApplicatorSentreheart20064—
+3K241111AMT Suture PasserApplied Medical Technology, Inc.20240—
+3K230746Non absorbable Surgical Polypropylene SutureShandong Haidike Medical Products Co., Ltd.20230—
+3K221767Surgical Sutures with or without NeedleHuaian Seamen Medical Technology Co., Ltd.20230—
+3K173747RexleneSm Eng Co., Ltd.20181—
+3K161633Rexlon, RexsilSm Eng Co., Ltd.20174—
+3K143582Mopylen, Resopren, Silk, Polyester, Nylon, Resolon, Polyamide Pseudo, SteelResorba Medical GmbH20150—
+3K142241LARIAT sulture Delivery DeviceSentreheart, Inc.20141—
+4K222944SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture…Safepath Medical, Inc.20240—
+4K232355Non absorbable Surgical Silk SutureShandong Haidike Medical Product Co., Ltd.20240—
+4K212888Golnit Nylon Monofilament SutureAntarma, LLC Dba Golnit Sutures20220—
+4K180701SafePath Suturing SystemSafepath Medical, Inc.20181—
+4K153096LARIAT RS Suture Delivery DeviceSentreheart, Inc.20150—