SAPPHIRE

Catheters, Transluminal Coronary Angioplasty, Percutaneous

ORBUSNEICH MEDICAL, INC.

The following data is part of a premarket notification filed by Orbusneich Medical, Inc. with the FDA for Sapphire.

Pre-market Notification Details

Device IDK103657
510k NumberK103657
Device Name:SAPPHIRE
ClassificationCatheters, Transluminal Coronary Angioplasty, Percutaneous
Applicant ORBUSNEICH MEDICAL, INC. 5363 N.W. 35TH AVE. Ft. Lauderdale,  FL  33309 -6315
ContactJohn Pazienza
CorrespondentJohn Pazienza
ORBUSNEICH MEDICAL, INC. 5363 N.W. 35TH AVE. Ft. Lauderdale,  FL  33309 -6315
Product CodeLOX  
CFR Regulation Number870.5100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-12-15
Decision Date2011-08-09
Summary:summary

Trademark Results [SAPPHIRE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SAPPHIRE
SAPPHIRE
98616734 not registered Live/Pending
Riverview Hospital
2024-06-24
SAPPHIRE
SAPPHIRE
98534123 not registered Live/Pending
Maryam Adil LLC
2024-05-04
SAPPHIRE
SAPPHIRE
98473495 not registered Live/Pending
Sapphire Retail Limited
2024-03-28
SAPPHIRE
SAPPHIRE
98153193 not registered Live/Pending
PPC Broadband, Inc.
2023-08-28
SAPPHIRE
SAPPHIRE
98035223 not registered Live/Pending
Sapphire Healthcare LLC
2023-06-09
SAPPHIRE
SAPPHIRE
97877876 not registered Live/Pending
RETRO MANUFACTURING, L.L.C.
2023-04-07
SAPPHIRE
SAPPHIRE
97750677 not registered Live/Pending
Sapphire Systems Limited
2023-01-11
SAPPHIRE
SAPPHIRE
97745482 not registered Live/Pending
With Purpose Enterprises
2023-01-07
SAPPHIRE
SAPPHIRE
97509761 not registered Live/Pending
PPC Broadband, Inc.
2022-07-19
SAPPHIRE
SAPPHIRE
97485488 not registered Live/Pending
Michael Allen Company LLC
2022-07-01
SAPPHIRE
SAPPHIRE
97469944 not registered Live/Pending
Hefei Anchovy Information Technology Co. LTD
2022-06-22
SAPPHIRE
SAPPHIRE
97439874 not registered Live/Pending
Azer Scientific Incorporated
2022-06-02

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