Atlas FDA

DWS

71 FDA 510(k) clearances · Product code

57 daysmedian time to decision
94 days90th percentile
71clearances measured

FDA profile

Official device name
Instruments, Surgical, Cardiovascular
Device class
Class I (low risk)
Regulation
21 CFR 870.4500
Medical specialty
Cardiovascular
Adverse events (MAUDE)
2020: 28 · 2021: 32 · 2022: 35 · 2023: 18 · 2024: 48 · 2026: 29
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
MYOCARDIAL LEAD IMPLANT TOOL, MODEL 10626 (K022238)Medtronic Vascular2002-10-09
OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006) (K964445)Dlp, Inc.1997-01-30
BURKE CONGENITAL THORACOSCOPY INSTRUMENTS (K962771)Pilling Weck, Inc.1996-11-19
RNS STERILE, DISPOSABLE DIGITAL ANGIOGRAPHIC TRAY (K955689)Contour Fabricators of Florida, Inc.1996-05-15
G.E. STERILE ANGIOGRAPHIC TRAY (K960139)GE Medical Systems1996-04-19
G.E. STERILE CT BIOPSY TRAY (K960144)GE Medical Systems1996-04-15
G.E. STERILE DIGITAL ANGIOGRAPHIC TRAY (K960143)GE Medical Systems1996-04-09
REPLACEMENT PARTS FOR CPI 6888 LEAD TUNNELER (K934727)Cardiac Pacemakers, Inc.1994-01-10
HYCULT DIAMOND CORONARY BYPASS KNIFE (K900379)St. Jude Medical, Inc.1990-03-19
INSULATION PAD (K896307)Bio-Vascular, Inc.1990-01-19
MODEL 6888 LEAD TUNNELER (K894738)Cardiac Pacemakers, Inc.1989-09-13
NEWCHILL(TM) CARDIAC INSULATOR (K892804)Acacia Laboratories, Inc.1989-07-14
MODIFIED STERILIZATION METHOD OF PTI HEART-LIFT (K893436)Pioneering Technologies, Inc.1989-07-14
MODIFIED EXTERNAL PAD (K891000)Instromedix, Inc.1989-05-19
DEKNATEL HIGH PRECISION VASCULAR PUNCH(TM) (K890432)Deknatel, Inc.1989-04-13
PHRENIC NERVE PAD & NERVE PAD W/1/4 PERCARDIAL (K890707)Dlp, Inc.1989-04-10
PTI INTRA-ART CORONARY ARTERY RETRACTION CLIP (K882981)Pioneering Technologies, Inc.1988-09-27
PTI HEART-LIFT(TM) CARDIAC ELEVATOR (STERILE) (K883135)Pioneering Technologies, Inc.1988-09-26
METATECH MICROCLIP APPLICATOR (K882367)Metatech Corp.1988-08-25
UMI DISPOSABLE BUTTERFLY STYLE PUNCTURE NEEDLE (K881796)Universal Medical Instrument Corp.1988-07-26
26MM DIAMETER HANCOCK* TROCAR BLADE AND TIP (K882479)Medtronic Blood Systems, Inc.1988-07-18
PTI HEART-LIFT(TM) CARDIAC SUPPORT SLING (STERILE) (K881717)Buckman Co., Inc.1988-07-05
CARDICAD(TM) (K881392)Medical/Surgical Specialties, Ltd.1988-05-31
BIOSURGE MODEL ILVC-1 (K875016)Biosurge, Inc.1988-02-29
CARDIOVASCULAR SURGICAL INSTRUMENTS (K874960)Solway, Inc.1988-02-05
MEDSURG CUSTOM CARDIOVASCULAR PROCEDURE TRAY (K864461)Medsurg Industries, Inc.1986-11-24
VICKERS ERGOMATIC MICROSURG INSTRU CARDIAC SET (K861745)Keeler Instruments, Inc.1986-05-13
SCANLAN TUNNELER, SHEATH & TIP (K851825)Scanlan Intl., Inc.1985-07-12
MANAN SELDINGER NEEDLE (K851833)Manan Manufacturing Co., Inc.1985-07-11
NAMAN POTTS COURNAND NEEDLE (K851832)Manan Manufacturing Co., Inc.1985-07-11
MANAN GWI GUIDE WIRE INTRODUCER (K851834)Manan Manufacturing Co., Inc.1985-07-11
MC-4000 SURGICAL INSTRUMENTS CARDIOVASCULAR (K851152)Cryomedics, Inc.1985-06-24
TELEFLEX MEDICAL INTRODUCER NEEDLE (K851140)Teleflexmedical, Inc.1985-06-19
LEMAITRE RETROGRADE VALVULOTOME-MANU-SURGICA INSTR (K850394)Vascutech, Inc.1985-04-24
GORE-TEX TUNNELER (K844584)W. L. Gore & Associates, Inc.1985-01-24
PMA ANGIOGRAPHY TRAY (K841468)Professional Medical Services1984-06-05
CATEGORY 1 CIRCULATORY SYSTEM DEVICE (K840305)Imm Enterprises , Ltd.1984-04-23
ROTARY VASCULAR KNIFE (K833547)Formedco, Inc.1984-01-26
LEATHER VALVE CUTTER (K831455)American V. Mueller1983-07-07
KELLY-WICK TANNELER (K830471)Intl. Medical Prosthetics Research1983-03-24
SCANLAN SINGLE-USE AORTA PUNCH (K823764)Scanlan Intl., Inc.1983-03-24
CARDIAC ELEVATOR (K823094)Cardio Surgical Research, Inc.1982-12-15
ROTARY VASCULAR KNIFE (K822829)Medco Products, Co., Inc.1982-11-17
LEATHER VALVULOTOME (K821569)American V. Mueller1982-05-27
DEKNATEL DISPOSABLE GOOSEN VASCULAR PNCH (K820258)Howmedica Corp.1982-03-02
VENOUS CANNULA TRAY (K813284)Cunningham Woodland, Inc.1981-12-29
NEOLOOPS (K810890)Medical Marketing Systems1981-08-31
DEKNATEL GOOSEN VASCULAR PUNCH BLADES (K802079)Howmedica Corp.1980-09-16
AIR ASPIRATOR NEEDLE (K801393)Texas Medical Products, Inc.1980-06-30
HANCOCK AORTIC PUNCH (K800122)Hancock Laboratories, Inc.1980-02-01
CASTROVIEJO VASCULAR SCISSORS (K792576)Edward Weck, Inc.1979-12-19
AORTIC OCCLUDER #000390 (K792088)Edward Weck, Inc.1979-10-26
CARDIOVASCULAR INSTRUMENTS-VARIOUS (K791710)Edward Weck, Inc.1979-09-12
SILICONE SURGICAL VESSEL LOOPS (K791370)Conphar, Inc.1979-08-03
GRAFT TUNNELER (K790124)Narco Scientific1979-02-08
SURGITEK DISPOSABLE FLO-RESTER (K781336)Medical Engineering Corp.1978-10-10
AORTIC PUMP (K780567)ETHICON, Inc.1978-04-28
IMPCO DISPOSABLE AORTIC PUNCH (K780247)Thoratec Laboratories Corp.1978-02-27
LEININGEO AORTIC PUNCH #310-395 & 397 (K771625)J. Jamner Surgical Instruments, Inc.1977-09-12
HUANG VEIN HOLDER, #21-8011 (K771026)Codman & Shurtleff, Inc.1977-06-20
ANASTOMASIS OCCLUDER (K761328)Medical Engineering Corp.1977-02-01
67-8006 DARLING-LINTON AORTIC TOURN. (K761161)Codman & Shurtleff, Inc.1976-12-06
SCISSOR - 1.5MM PROBE POINT, ANGLED (K760792)V. Mueller O.V. Baxter Healthcare Corp.1976-11-11
COOLEY ANGLED SCISSOR - 1MM PROBE POINT (K760791)V. Mueller O.V. Baxter Healthcare Corp.1976-11-11
TIBIAL ARTERY CLAMP W/ATRAUGRIP JAWS (K760648)Pilling Co.1976-09-21
CAROTID ARTERY ARTERIOTOMY CLOSURE CLAMP (K760645)Pilling Co.1976-09-21
CAROTID ARTERY CLAMP W/PILLING LMM (K760646)Pilling Co.1976-09-21
SMALL VESSEL CANNULA (K760624)Cobe Laboratories, Inc.1976-09-17
CATHETER, ARGYLE THORACIC (K760351)Sherwood Medical Industries1976-08-23
TAPE, VASCULAR, 1/4 DACRON (K760087)Meadox Medicals, Div. Boston Scientific Corp.1976-07-20
CATHETER, THORACIC DRAIN (K760136)Sherwood Medical Industries1976-07-20

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