Caraballo Consulting Associates

FDA Filings

This page includes the latest FDA filings for Caraballo Consulting Associates. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 1055965
• FEI Number: 1000113395
• Name: SCION CARDIO-VASCULAR, INC.
• Owner & Operator: Caraballo Consulting & Associates
• Contact Address: 14256 S.W. 119th Avenue ; Miami FL 33186 US
• Official Correspondent:
  • Alina Caraballo
  • 1-305-7245939-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 14256 SW 119th Ave ; Miami, FL 33186 US
• Establishment Type: Develop Specifications But Do Not Manufacture At This Facility

• Registration Number: 3003135358
• FEI Number: 3003135358
• Name: Scion BioMedical Manufacturing Corp.
• Owner & Operator: Caraballo Consulting & Associates
• Contact Address: 14256 S.W. 119th Avenue ; Miami FL 33186 US
• Official Correspondent:
  • Alina Caraballo
  • 1-305-7245939-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 1725 Ocean Ave Bldg 3 ; RAYMOND, WA 98577 US
• Establishment Type:
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
PMN K052509 | HCG Scion BioMedical Manufacturing Corp. [Caraballo Consulting & Associates]	M-BOLUS Embolic Microspheres	2019-06-28
PMN K052509 | HCG SCION CARDIO-VASCULAR, INC. [Caraballo Consulting & Associates]	M-BOLUS Embolic Microspheres	2019-06-28
PMN K112961 | FRO Scion BioMedical Manufacturing Corp. [Caraballo Consulting & Associates]	Clo-Sur Plus P.A.D.	2012-12-04
PMN K112961 | FRO SCION CARDIO-VASCULAR, INC. [Caraballo Consulting & Associates]	Clo-Sur Plus P.A.D.	2012-12-04
NAC Scion BioMedical Manufacturing Corp. [Caraballo Consulting & Associates]	Clo-Sur P.A.D.	2012-12-04
NAC SCION CARDIO-VASCULAR, INC. [Caraballo Consulting & Associates]	Clo-Sur P.A.D.	2012-12-04
PMN K092552 | FRO Scion BioMedical Manufacturing Corp. [Caraballo Consulting & Associates]	Clo-Sur Plus P.A.D.	2009-11-09
PMN K092552 | FRO SCION CARDIO-VASCULAR, INC. [Caraballo Consulting & Associates]	Clo-Sur Plus P.A.D.	2009-11-09
PMN K032986 | FRO Scion BioMedical Manufacturing Corp. [Caraballo Consulting & Associates]	Clo-Sur Plus P.A.D.	2009-08-21
PMN K032986 | FRO SCION CARDIO-VASCULAR, INC. [Caraballo Consulting & Associates]	Clo-Sur Plus P.A.D.	2009-08-21