Product Code: LIT


Products Classified as LIT

863Catheter, Angioplasty, Peripheral, TransluminalPercutaneous Catheter.

Total Product Life Cycle (TPLC) Devices

863Catheter, Angioplasty, Peripheral, TransluminalPercutaneous Catheter.

FDA Consensus Standards

Catheter, Angioplasty, Peripheral, Transluminal [37531]21 CFR §870.1250 🔎
Catheter, Angioplasty, Peripheral, Transluminal [31783]21 CFR §870.1250 🔎
Catheter, Angioplasty, Peripheral, Transluminal [37931]21 CFR §870.1250 🔎

Pre-market Approvals for LIT

P950020CUTTING BALLOON MONORAIL(MR)/OVER THE WIRE(OTW)Boston Scientific Corp.

Pre-market Notifications for LIT

K221414ENROUTE Enflate Transcarotid RX Balloon Dilatation CatheterSilk Road Medical, Inc.
K221339Paladin Carotid Post-Dilation Balloon System With Integrated Embolic ProtectionContego Medical Inc.
K221057Viatrac 14 Plus Peripheral Dilatation CatheterAbbott Vascular
K220410Ebony HP PTA OTW 0.035 CatheterNatec Medical Ltd.
K214038Oscar Peripheral Multifunctional Catheter SystemBIOTRONIK, Inc.
K213631Chocolate PTA Balloon CatheterMedtronic, Inc.
K211044Sublime Radial Access 018 RX Dilatation CatheterCreagh Medical Ltd. (a Wholly Owned Subsidiary Of Surmodics,
K210626SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation CatheterCordis Corporation
K202231JADEOrbusNeich Medical (Shenzhen) Co., Ltd.
K201377SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation CatheterCordis Corporation
K201333SABER .035 PTA Dilatation CatheterCordis Corporation
K201170Athletis PTA Balloon Dilatation CatheterBoston Scientific Corporation
K200700Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation CatheterCreagh Medical Ltd.
K192907Advocate PTA CatheterMerit Medical Systems Inc.
K192399Infinity Angioplasty Balloon CatheterInfinity Angioplasty Balloon Company, LLC

Global Unique Device Identification Database

00383790004350Catheter, angioplasty, peripheral, transluminal
00383790004343Catheter, angioplasty, peripheral, transluminal
00383790004336Catheter, angioplasty, peripheral, transluminal
00383790004329Catheter, angioplasty, peripheral, transluminal
00383790004312Catheter, angioplasty, peripheral, transluminal
00383790004305Catheter, angioplasty, peripheral, transluminal
00383790004299Catheter, angioplasty, peripheral, transluminal
00383790004282Catheter, angioplasty, peripheral, transluminal
00383790004275Catheter, angioplasty, peripheral, transluminal
00383790004268Catheter, angioplasty, peripheral, transluminal
00383790004251Catheter, angioplasty, peripheral, transluminal
00383790004244Catheter, angioplasty, peripheral, transluminal
00383790004237Catheter, angioplasty, peripheral, transluminal
00383790004220Catheter, angioplasty, peripheral, transluminal
00383790004213Catheter, angioplasty, peripheral, transluminal

Maude Adverse Events

COYOTE ESBOSTON SCIENTIFIC CORPORATION2020-03-31
STERLINGBOSTON SCIENTIFIC CORPORATION2020-03-31
GLADIATOR ELITEBOSTON SCIENTIFIC CORPORATION2020-03-31
GLADIATOR ELITEBOSTON SCIENTIFIC CORPORATION2020-03-31
STERLINGBOSTON SCIENTIFIC CORPORATION2020-03-31
STERLINGBOSTON SCIENTIFIC CORPORATION2020-03-31
POWERFLEX P3 F5 6X4 80CORDIS CASHEL2020-03-31
STERLINGBOSTON SCIENTIFIC CORPORATION2020-03-31
SABER RX5MM10CM155CORDIS CORPORATION2020-03-31
2CM PERIPHERAL CUTTING BALLOONBOSTON SCIENTIFIC CORPORATION2020-03-31
2CM PERIPHERAL CUTTING BALLOONBOSTON SCIENTIFIC CORPORATION2020-03-30
2CM PERIPHERAL CUTTING BALLOONBOSTON SCIENTIFIC CORPORATION2020-03-30
2CM PERIPHERAL CUTTING BALLOONBOSTON SCIENTIFIC CORPORATION2020-03-30
2CM PERIPHERAL CUTTING BALLOONBOSTON SCIENTIFIC CORPORATION2020-03-30
2CM PERIPHERAL CUTTING BALLOONBOSTON SCIENTIFIC CORPORATION2020-03-30
2CM PERIPHERAL CUTTING BALLOONBOSTON SCIENTIFIC CORPORATION2020-03-30
SABER RX4MM30CM155CORDIS CORPORATION2020-03-30
SABER 6MM20CM 150CORDIS CORPORATION2020-03-30
SABER 3MM4CM 90CORDIS CORPORATION2020-03-30
ARMADA 35 PTA CATHETERABBOTT VASCULAR2020-03-30
COYOTE ESBOSTON SCIENTIFIC CORPORATION2020-03-29
COYOTEBOSTON SCIENTIFIC CORPORATION2020-03-29
SYMMETRYBOSTON SCIENTIFIC CORPORATION2020-03-27
2CM PERIPHERAL CUTTING BALLOONBOSTON SCIENTIFIC CORPORATION2020-03-27
AVIATOR PLUS .014 6.0X40 142CMCORDIS CORPORATION2020-03-27
COYOTE ESBOSTON SCIENTIFIC CORPORATION2020-03-27
COYOTE ESBOSTON SCIENTIFIC CORPORATION2020-03-27
COYOTE ESBOSTON SCIENTIFIC CORPORATION2020-03-27
2CM PERIPHERAL CUTTING BALLOONBOSTON SCIENTIFIC CORPORATION2020-03-27
COYOTE ESBOSTON SCIENTIFIC CORPORATION2020-03-26
COYOTEBOSTON SCIENTIFIC CORPORATION2020-03-26
COYOTE ESBOSTON SCIENTIFIC CORPORATION2020-03-26
ARMADA 35 PTA CATHETERABBOTT VASCULAR2020-03-26
COYOTE ESBOSTON SCIENTIFIC CORPORATION2020-03-26
XXL VASCULARBOSTON SCIENTIFIC CORPORATION2020-03-26
2CM PERIPHERAL CUTTING BALLOONBOSTON SCIENTIFIC CORPORATION2020-03-26
2CM PERIPHERAL CUTTING BALLOONBOSTON SCIENTIFIC CORPORATION2020-03-26
PACIFIC XTREMEMEDTRONIC MEXICO2020-03-26
COYOTEBOSTON SCIENTIFIC CORPORATION2020-03-25
COYOTEBOSTON SCIENTIFIC CORPORATION2020-03-25
STERLINGBOSTON SCIENTIFIC CORPORATION2020-03-25
CHARGERBOSTON SCIENTIFIC CORPORATION2020-03-25
STERLINGBOSTON SCIENTIFIC CORPORATION2020-03-25
POWERFLEX EXTREME 6X4 80CMCORDIS CORPORATION2020-03-25
COYOTE ESBOSTON SCIENTIFIC CORPORATION2020-03-25
COYOTE ESBOSTON SCIENTIFIC CORPORATION2020-03-25
PACIFIC PLUSINVATEC SPA2020-03-25
ADVANCE 35 LP LOW PROFILE BALLOON CATHETERCOOK INC2020-03-25
ARMADA 18 PTA CATHETERABBOTT VASCULAR2020-03-24
ARMADA 18 PTA CATHETERABBOTT VASCULAR2020-03-24
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