Product Code: NIQ


Products Classified as NIQ

1050Coronary Drug-eluting Stent

Total Product Life Cycle (TPLC) Devices

1050Coronary Drug-eluting Stent

FDA Consensus Standards

Coronary Drug-Eluting Stent [31108]21 CFR Unclassified 🔎
Coronary Drug-Eluting Stent [30301]21 CFR Unclassified 🔎
Coronary Drug-Eluting Stent [38113]21 CFR Unclassified 🔎
Coronary Drug-Eluting Stent [33194]21 CFR Unclassified 🔎
Coronary Drug-Eluting Stent [38690]21 CFR Unclassified 🔎
Coronary Drug-Eluting Stent [38115]21 CFR Unclassified 🔎
Coronary Drug-Eluting Stent [38470]21 CFR Unclassified 🔎
Coronary Drug-Eluting Stent [33890]21 CFR Unclassified 🔎
Coronary Drug-Eluting Stent [32691]21 CFR Unclassified 🔎
Coronary Drug-Eluting Stent [38114]21 CFR Unclassified 🔎
Coronary Drug-Eluting Stent [38909]21 CFR Unclassified 🔎

Pre-market Approvals for NIQ

P950020FLEXTOME CUTTING BALLOONBoston Scientific Corp.
P170030ORSIRO Sirolimus Eluting Coronary Stent SystemBiotronik, Inc
P160043Resolute Onyx Zotarolimus Eluting Coronary Stent SystemMEDTRONIC VASCULAR
P110013Resolute Integrity Zotarolimus-Eluting Coronary Stent SystemMedtronic Vascular
P070015XIENCE V and XIENCE nano Everolimus Eluting Coronary Stent SystemsABBOTT VASCULAR INC.
P110019XIENCE PRIME, SV, LL; XIENCE Xpedition, SV, LL; Everolimus Eluting Coronary Stent Systems;XIENCE Alpin and Sierra EverolABBOTT VASCULAR
P170008EluNIRâ„¢ Ridaforolimus Eluting Coronary Stent SystemMedinol, Ltd.
P110010PROMUS Element Plus Everolimus Eluting Platinum Chromium Coronary Stent System Monorail (MR) and Over-THe-Wire (OTW); PrBoston Scientific Corp.
P150003SYNERGY Everolimus Eluting Platinum Chromium Coronary Stent System Monorail (MR) and Over-The-Wire (OTW)BOSTON SCIENTIFIC CORPORATION

Global Unique Device Identification Database

00613994793508Coronary drug-eluting stent
00613994793492Coronary drug-eluting stent
00613994793485Coronary drug-eluting stent
00613994793478Coronary drug-eluting stent
00613994793461Coronary drug-eluting stent
00613994793454Coronary drug-eluting stent
00613994793447Coronary drug-eluting stent
00613994793430Coronary drug-eluting stent
00613994793423Coronary drug-eluting stent
00613994793416Coronary drug-eluting stent
00613994793409Coronary drug-eluting stent
00613994793393Coronary drug-eluting stent
00613994793386Coronary drug-eluting stent
00613994793379Coronary drug-eluting stent
00613994793362Coronary drug-eluting stent

Maude Adverse Events

ORSIRO 2.25/30BIOTRONIK AG, BUELACH, SWITZERLAND2020-03-31
ORSIRO (US) 3.0/35BIOTRONIK AG, BUELACH, SWITZERLAND2020-03-31
SYNERGYBOSTON SCIENTIFIC CORPORATION2020-03-31
XIENCE SIERRAABBOTT VASCULAR2020-03-31
RX XIENCE XPEDITION 48ABBOTT VASCULAR2020-03-31
UNKNOWN XIENCEABBOTT VASCULAR2020-03-31
UNKNOWN XIENCEABBOTT VASCULAR2020-03-31
XIENCE XPEDITIONABBOTT VASCULAR2020-03-31
SYNERGYBOSTON SCIENTIFIC CORPORATION2020-03-31
SYNERGYBOSTON SCIENTIFIC CORPORATION2020-03-31
SYNERGYBOSTON SCIENTIFIC CORPORATION2020-03-31
RESOLUTE ONYX RXMEDTRONIC IRELAND2020-03-31
RX XIENCE XPEDITION 48ABBOTT VASCULAR2020-03-31
XIENCE DRUG ELUTING CORONARY STENTABBOTT VASCULAR2020-03-31
XIENCE DRUG ELUTING CORONARY STENTABBOTT VASCULAR2020-03-31
SYNERGYBOSTON SCIENTIFIC CORPORATION2020-03-31
XIENCE DRUG ELUTING CORONARY STENTABBOTT VASCULAR2020-03-31
XIENCE DRUG ELUTING CORONARY STENTABBOTT VASCULAR2020-03-31
RESOLUTE ONYX RXMEDTRONIC IRELAND2020-03-31
RESOLUTE ONYX RXMEDTRONIC IRELAND2020-03-31
RESOLUTE INTEGRITY RXMEDTRONIC IRELAND2020-03-31
RESOLUTE ONYX?MEDTRONIC, INC.2020-03-31
ELUNIR RIDAFOROLIMUS ELUTING CORONARY STENT SYSTEMMEDINOL LTD.2020-03-31
ELUNIR RIDAFOROLIMUS ELUTING CORONARY STENT SYSTEMMEDINOL LTD.2020-03-31
ORSIRO 2.75/40BIOTRONIK AG, BUELACH, SWITZERLAND2020-03-30
SYNSIRO 3.0/15BIOTRONIK AG, BUELACH, SWITZERLAND2020-03-30
ORSIRO 2.75/13BIOTRONIK AG, BUELACH, SWITZERLAND2020-03-30
ORSIRO 3.0/26BIOTRONIK AG, BUELACH, SWITZERLAND2020-03-30
ORSIRO 3.5/22BIOTRONIK AG, BUELACH, SWITZERLAND2020-03-30
ORSIRO 3.0/40BIOTRONIK AG, BUELACH, SWITZERLAND2020-03-30
ORSIRO 3.5/30BIOTRONIK AG, BUELACH, SWITZERLAND2020-03-30
ORSIRO 2.25/40BIOTRONIK AG, BUELACH, SWITZERLAND2020-03-30
XIENCE SIERRAABBOTT VASCULAR2020-03-30
PROMUS ELEMENTBOSTON SCIENTIFIC CORPORATION2020-03-30
PROMUS ELEMENT PLUSBOSTON SCIENTIFIC CORPORATION2020-03-30
SYNERGYBOSTON SCIENTIFIC CORPORATION2020-03-30
PROMUS PREMIERBOSTON SCIENTIFIC CORPORATION2020-03-30
RX PRIMEABBOTT VASCULAR2020-03-30
XIENCE ALPINEABBOTT VASCULAR2020-03-30
PROMUS ELEMENTBOSTON SCIENTIFIC CORPORATION2020-03-30
SYNERGYBOSTON SCIENTIFIC CORPORATION2020-03-30
SYNERGYBOSTON SCIENTIFIC CORPORATION2020-03-30
SYNERGYBOSTON SCIENTIFIC CORPORATION2020-03-30
XIENCE XPEDITIONABBOTT VASCULAR2020-03-30
ELUNIR RIDAFOROLIMUS ELUTING CORONARY STENT SYSTEMMEDINOL LTD.2020-03-30
XIENCE XPEDITIONABBOTT VASCULAR2020-03-30
SYNERGYBOSTON SCIENTIFIC CORPORATION2020-03-30
SYNERGYBOSTON SCIENTIFIC CORPORATION2020-03-30
RESOLUTE INTEGRITY RXMEDTRONIC IRELAND2020-03-30
RESOLUTE ONYX RXMEDTRONIC IRELAND2020-03-30
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