Product Code: DXC FDA class 2 21 CFR 870.4450

Clamp, Vascular

Cardiovascular

The Vascular Clamp is a cardiovascular surgical instrument used to temporarily occlude blood flow through a vessel segment during vascular repair, anastomosis, or other surgical interventions, allowing the surgeon to operate in a bloodless field. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DXC and it is regulated under 21 CFR 870.4450 within the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.

510(k)s
204
FEI Numbers
186
Registration Numbers
186
Unique Applicants
127
Years Active
49

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Basic Information

Product Code
DXC
Device Class
FDA class 2
Regulation Number
870.4450
Medical Specialty
Cardiovascular
Review Panel
CV
Submission Type
1

Device Characteristics

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

510(k) Clearance History

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Related 510(k) Clearances

This FDA classification is associated with 204 510(k) clearances via K numbers.

K Number Device Name
K260105 Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts
K252772 Arc Adjustable Radial Cuff Compression Device
K254060 Life Saving Tourniquet
K243627 Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC)
K253070 Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)
K232577 Radial Compression Device
K230281 PICOCLAMP
K221661 Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)
K230248 VIOLA
K222182 Radial Artery Compression Tourniquets
K221843 GEM Biover Microvascular Clamps
K213531 TR BAND Radial Compression Device
K210681 SiteSeal SV
K210324 V. Mueller Cosgrove Flex Clamps, Model Number-CV1033, CV1061, CV1133, CV1161, CV1186
K210006 MI DeTACH
K203307 VIOLA
K203803 VASOBand Vascular Compression Device
K201695 Patent Hemostasis Band (PH Band)
K192413 SiteSeal Femoral Compression Device
K191827 Sunmed Disposable Angio-Closure Pads
K190351 Site Seal SV
K190318 VASOBand Vascular Compression Device
K180723 PreludeSYNC DISTAL Radial Compression System
K173563 ARC ADJUSTABLE RADIAL CUFF COMPRESSION DEVICE
K170958 ChitoPulse 9in / 23 cm, ChitoPulse 12in / 30.5 cm, ChitoPulse 15in / 38 cm
K163693 IntraClude Intra-Aortic Occlusion Device
K162988 PreludeSYNC Radial Compression Device
K162027 TRAcelet Compression Device
K161315 Vein Clamps, Artery Clamps
K153259 VasoStat Hemostasis Device
K152525 TR BAND Radial Compression Device
K151363 Zephyr Vascular Compression Device
K143078 Bookwalter Gordon Adjustable Compression Element
K150813 iTClamp50
K141685 CROC
K142122 RADAR VASCULAR COMPRESSION DEVICE
K142359 Vasc Band hemostat
K140805 ITCLAMP 50
K132293 SYVEK RADIAL BAND
K133029 ABDOMINAL AORTIC AND JUNCTIONAL TOURNIQUET (AAJT) DEVICE
K132651 ITCLAMP 50
K131411 COSEAL
K132175 EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER
K123571 CARDIO VISION MICS AORTIC CLAMPS
K131561 SAM JUNCTIONAL TOURNIQUET
K130382 HEARTSTRING III PROXIMAL SEAL SYSTEM
K123041 VASOSTAT HEMOSTASIS DEVICE
K123551 ITCLAMP 50
K123077 VASCULAR CLAMPS
K130482 COMBAT READY CLAMP
K130124 CATALYST II AND III
K123694 SAM JUNCTIONAL TOURNIQUET
K123194 JUNCTIONAL EMERGENCY TREATMENT TOOL MODEL 30-0088
K123035 SEAL ONE
K122405 AIR-BAND RADIAL COMPRESSION DEVICE
K120492 K2 MEDICAL VASCULAR CLAMPS
K113600 IM BAND
K112662 MICROFRANCE(R) WORMALD VASCULAR CLAMP
K113182 EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER
K112384 ABDOMINAL TOURNIQUET SYSTEM
K112694 EDWARDS LIFESCIENCES ENDOCLAMP AORTIC CATHETER
K111837 RADIAL ARTERY COMPRESSION TOURNIQUET
K110148 WEXLER VASCULAR CLAMP SERIES
K110193 FEMOSTOP PLYS, FEMOSTOP HD, FEMOSTOP COMPRESSION ARCH; FEMOSTOP II PLUS SET; FEMOSTOP II PLUS ARCH, BILATERAL ADAPTER; F
K102048 ATRAUMATIC VASCULAR CLAMPS
K102025 COMBAT READY CLAMP
K092503 RADAR VASCULAR COMPRESSION DEVICES
K092544 INSTRUMED VASCULAR CLAMPS
K090286 PRESSUREMATE MANUAL FEMORAL ACCESS COMPRESSION DEVICE
K082930 CARDIVA CATALYST III SYSTEM WITH PROTAMINE SULFATE
K080206 MODIFICATION TO FEMOSTOP FEMORAL COMPRESSION SYSTEM
K080169 HEARTSTRING III PROXIMAL SEAL SYSTEM
K072834 SIBEL SA VASCULAR CLAMP
K072297 BOOMERANG CATALYST/BOOMERANG CATALYST II SYSTEM
K072167 COMFORTPRESS VASCULAR COMPRESSION ASSIST DEVICE
K071225 INNOVASA STAT*SEAL TOPICAL HEMOSTAT
K070661 VITALCOR FEATHERWEIGHT VASCULAR CLAMPS
K070380 PORTACLAMP FLEX
K070423 TR BAND
K070485 BOOMERANG WIRE /BOOMERANG PLUS WIRE SYSTEM, MODEL# B PLUS WIRE 58L
K063871 D-STAT HANDLE, MODEL 8500-053
K070323 TEMPORARY LIMB SALVAGE SHUNT
K062569 SAFEGUARD 24 CM PRESSURE ASSISTED DRESSING
K061484 MODIFICATION TO: SMITHWICK CAROTID SHUNT
K051817 BOOMERANG CLOSUREWIRE VASCULAR CLOSURE SYSTEM
K062474 SMITHWICK CAROTID SHUNT
K061075 BOOMERANG WIRE
K053300 SYVEKEXCEL
K053398 COMPASS COMPRESSION ASSIST HANDLE
K050146 VASCULAR SOLUTIONS D-STAT CLAMP ACCESSORY
K041486 VASOSTASIS VASCULAR CLOSURE SYSTEM
K040730 VASCULAR SOLUTIONS D-STAT CLAMP HEMOSTATIC CLAMP
K040615 COMPRESSAR SUPERCOMFORT DISC AND STRONGARM SUPERCOMFORT SYSTEM
K033085 PORTACLAMP
K032125 CSTAT, MODELS 09-0014-01 AND 09-0014-02
K031812 TRANSVAGINAL DOPPLER CLAMP, MODELS: 09-0016-01, 09-0016-02, 09-0016-03
K032589 ENCLOSE II ANASTOMOSIS ASSIST DEVICE
K023682 ENCLOSE ANASTOMOSIS ASSIST DEVICE
K024107 FEMOSTOP FEMORAL COMPRESSION SYSTEM
K023154 VCS-A SERIES CLAMP WITH DOPPLER ULTRASOUND, MODEL 09-0007-01 AND 09-0007-02
K014277 KSEA DEPLOYABLE CARDIOVASCULAR CLAMP
K021608 SMITHWICK CAROTID SHUNT
K022754 S&T SINGLE USE MICRO ANASTOMOSIS CLAMP
K011208 BIOVER
K022880 GUIDANT PROXIMAL SEAL SYSTEM, MODELS PSS-4500 & PS-4500
K010727 FLEXLINE CLAMP
K012041 THE HAMMER MODEL H100
K011863 VCS-A SERIES CLAMP
K010694 INCLUDER CLAMP
K010785 KSEA DION-GRACIA SET
K011078 MALLEABLE SHAFT CLAMP
K010117 GUIDANT AXIUS CORONARY SHUNT
K002915 FLEXIBLE OCCLUSION SYSTEM
K002767 COMPRESSAR FEMORAL ACCESS COMPRESSION DEVICE
K992980 ENGAGE JAW INSERTS
K000098 SOFTLINE SPRING CLIP
K992174 PILLING WECK SURGICAL AORTIC SPOON-JAW CLAMP
K992053 AESCULAP VASCULAR INSTRUMENTS
K992640 SLIMLINE SURGICAL CLAMP; SLIMLINE JAW INSERTS
K984214 CORDIS ENDOVASCULAR TEMPORARY OCCLUSION BALLOON CATHETER
K991589 FLEXIBLE VASCULAR CLAMP, VERSION 2
K982365 ATRAUMATIC VASCULAR CLAMPS, MODEL #'S 22-XXXX, 23-XXXX, 03-60XX, 25-XXXX MICRO VASCULAR CLAMPS MODEL # 75-0XXX, ATRAUMAT
K982278 MICRINS MICRO ANASTOMOSIS CLAMP
K990573 ESTECH ARTERIAL REMOTE ACCESS PERFUSION CANNULA
K983471 FEMOSTOP COMPRESSION ARCH, FEMOSTOP PUMP, FEMOSTOP BILATERAL ADAPTER
K980631 EMBOL-X AORTIC OCCLUSION AND CARDIOPLEGIA CANNULA
K982182 FEMOSTOP II PLUS DISPOSABLE SET MODEL 11166, FEMOSTOP II PLUS COMPRESSION ARCH MODEL 11168, FEMOSTOP II BILATERAL ADAPT0
K972689 CAOW HEMOSTASIS SYSTEM
K981624 FLO-THRU
K980128 BALADI INVERTER WITH COAXIAL AORTIC PUNCH
K981956 DEGANIA SILICONE IDENTI LOOPS
K980087 PRESDURE PRODUCTS PRESSURE PADS, MODELS P100, P110, P120, P130, P200, P210, P220, P230, P300, P310, P320, P330
K980002 KOALA VASCULAR CLAMPS AND INSERTS
K974769 COSGROVE CLAMP
K980898 FEMOSTOP II DISPOSABLE SET, FEMOSTOP II COMPRESSION ARCH, FEMOSTOP II PUMP, FEMOSTOP II BILATERAL ADAPTER
K973080 SURGICAL VASCULAR CLAMP
K973132 EZ HOLD 1 LBS., EZ HOLD 2 LBS
K964663 FAVP: FEMORAL ARTERY VASCULAR PAD - MODEL NUMBER PAD2EK-01, PAD2EK-2X, PAD5EK-R, PAD5EK-RX, PAD6EK-F AND PAD6EK-FX
K973216 FAVC-HH: FEMORAL ARTERY VASCULAR CLAMP-HAND HELD: 1/2 & 3 POUNDS (RMDS810T/815T/820T)
K970638 CTS MIDCAB FIXEDN DIAMETER CORONARY SHUNT
K970611 ORIGIN CARDIAC STABLIZER OCCLUDER
K970027 FAVC-M: FEMORAL ARTERY VASCULAR CLAMP-MOBILE (MODEL M100-M200) FAVC-M FEMORAL ARTERY VASCULAR CLAMP-MOBILE ADJ BELT 6005
K964251 OCCLUSION CLAMP** DEVICE
K964161 HEARTPORT ENDOAORTIC CLAMP
K963503 CTS MIDCAB CORONARY SHUNT
K963716 MICS DEVICE SYSTEM
K964662 FAVC: FEMORAL ARTERY VASCULAR CLAMP - MODEL NUMBER RMDS 1000-15, RMDS 1000-20, RMDS 2000-15, RMDS 2000-20, RMDS 3000-15
K964547 DEGANIA SILICONE INDENTI LOOPS
K962366 HEARTPORT CABLE BULLDOG CLAMP
K962668 AMR-ACV CLAMPS
K955827 DANESHVAR WOUND SUPPORT UNIT
K962858 HEARTPORT ENDOVASCULAR CARDIOPULMONARY BYPASS SYSTEM ANTEGRADE SYTEM (CATALOG NUMBER ECPB-A) ANTEGRADE/RETROGRADE SYSTEM
K962510 HEARTPORT ENDOAORTIC CLAMP
K955742 D. DEVICE II
K955270 TAPE & BANDAGE, ADHESIVE
K961461 DANESHVAR'S DEVICE (MODIFICATION)
K961100 MICRO ANASTOMOSIS CLAMP
K955132 HEARTPORT ENDOAORTIC CLAMP
K954669 FEMOSTOP, FEMOSTOP PUMP
K951413 FOGARTY-HYDRAGRIP SURGICAL CLAMPS
K944259 FEMOSTOP II
K943948 PROTECTIVE SHORTS
K950492 ATRAUMAX SURGICAL CLAMP
K935964 IDEAS OCCLUDER
K935494 DANESHVAR'S DEVICE
K942812 FLO-RESTER DISPOSABLE VESSEL OCCLUDER
K925809 COMPRESSAR UNIVERSAL (TM) SYSTEM
K923085 QUICKLAMP SYSTEM
K920936 RMI EXTERNAL CORONARY ARTERY OCCLUDER
K921399 OCCLUSION BALLON CATHETER MODIFICAION
K920501 SILCLAMPS DEGANIA SILICONE
K915280 FEMOSTOP
K914149 FEMORAL ARTERY PRESSURE PAD/DISK
K910221 RMI VASCULAR TOURNIQUET KIT
K901628 APPLIED VASCULAR DEVICES 6MM TRACTION CLIP
K901565 ATRAUMAX SURGICAL CLAMP MODEL FOG-5048, 75MM SIDE
K897075 PTI INTRA-ART(TM) ANSARI SAPHENOUS VEIN HOLDER
K885161 VOSS VEIN CLAMP
K895691 VASCULAR CLAMP
K894670 GENERAL SURGICAL INSTRUMENTS
K891296 ATRAUMAX(TM) SURGICAL CLAMPS
K883790 SURGICAL CLAMP INSERTS
K883696 FLO-RESTER
K882879 PTI INTRA-ART(TM) CORONARY ARTERY OCCLUDERS (STER)
K881448 #557 DISPOSABLE CARDIOVASCULAR CLAMP
K881447 METATECH METAL MICROCLIP
K881158 VASCULAR CLAMP
K875090 AUTO SUTURE DISPOSABLE APPROXIMATING CLAMP*
K863427 CLAMPEASE FA
K861924 MICRO ANASTOMOSIS CLAMP
K851739 DUNN VESSEL OCCLUDER-STERILE
K852479 PULMONARY VEIN CLAMP
K831809 FOGARTY OCCLUDER PAD
K832554 FOGARTY 6MM SOFTJAW CLIP
K820949 P-S BERLIN VESSEL CLAMP
K813499 OMED DISPOSABLE BULLDOG
K813062 VASCULAR PAWS
K810162 FOGARTY SOFTJAW 6MM SPRING CLIP, #614-06
K802244 VESSEL RETRACTOR, #600732
K801395 VASCULAR CLAMP
K791098 SINGLE-USE MINI-BULLDOG
K772137 VEIN CLAMPS
K770503 LOUISVILLE CLAMP PRODUCT #65-172
K761169 GRANT MODIF OF DEBAKEY ABDOM AORTA CLMP

FEI Numbers

This FDA classification entry is associated with 186 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 186 registration numbers. Click on an entry to view related FDA registrations.