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Scientia Vascular, Inc.

United States·US-MF-000018661

Last updated June 8, 2026

Information

Country: United States
Address: 2460 South 3270 West, West Valley City, United States
Website: scientiavascular.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1 (888) 385-9016
PRRC Contact: Bailey Johannsen
EUDAMED SRN: US-MF-000018661
FDA FEI Number: —
DUNS Number: —

Catalogue (48)

Device	Model / Reference	Registries	Class	Status
Plato	17-160-045	FDA UDI	Class II	Active
Aristotle	14-200-004	FDA UDI	Class II	Active
Volo	14-300-001	FDA UDI	Class II	Unknown
Socrates	TS-254-110	FDA UDI	Class II	Active
Plato	27B	FDA UDI	Class II	Active
Aristotle	18-200-001	FDA UDI	Class II	Active
Aristotle	14-300-004	FDA UDI	Class II	Active
Aristotle	14-300-002	FDA UDI	Class II	Active
Socrates	SC038-127-001	FDA UDI	Class II	Active
Plato	17-160-090	FDA UDI	Class II	Active
Volo	14-300-002	FDA UDI	Class II	Unknown
Aristotle	14-200-003	FDA UDI	Class II	Active
Aristotle	14-300-003	FDA UDI	Class II	Active
Aristotle	ACL-300-002	FDA UDI	Class II	Active
Volo	14-200-002	FDA UDI	Class II	Unknown
Aristotle	14-200-002	FDA UDI	Class II	Active
Plato	17-160-000	FDA UDI	Class II	Active
Aristotle	01862	FDA UDI	Class II	Active
Aristotle	14-200-001	FDA UDI	Class II	Active
Aristotle	01864	FDA UDI	Class II	Active
Aristotle	01863	FDA UDI	Class II	Active
Socrates	SC038-156-001	FDA UDI	Class II	Active
Aristotle	14-300-001	FDA UDI	Class II	Active
Socrates	SC038-127-001	FDA UDI	Class II	Active
Socrates	SC038-156-001	FDA UDI	Class II	Active
Volo	14-200-001	FDA UDI	Class II	Unknown
Aristotle	ACL-200-002	FDA UDI	Class II	Active
Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm, Standard Profile ; Aristotle 18 Guidewire, 200cm, Support Profile	K183608	FDA 510(k)	Class II	Active
Socrates 38 Catheter	K242301	FDA 510(k)	Class II	Active
Socrates Aspiration System	K223913	FDA 510(k)	Class II	Active
Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire	K253579	FDA 510(k)	Class II	Active
Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire, 200cm, Support Profile, Aristotle 14 Guidewire, 300cm, Soft Profile, Aristotle 14 Guidewire, 300cm, Support Profile	K173235	FDA 510(k)	Class II	Active
Plato MICROCATH 27B Microcatheter	K143398	FDA 510(k)	Class II	Active
Aristotle Colossus Guidewire	K222437	FDA 510(k)	Class II	Active
Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire	K220398	FDA 510(k)	Class II	Active
Plato 17 Microcatheter	K223560	FDA 510(k)	Class II	Active
Plato MICROCATH 27B Microcatheter	K170406	FDA 510(k)	Class II	Active
Aristotle 18 Guidewire; Aristotle 24 Guidewire	K231954	EUDAMEDFDA 510(k)FDA UDI	Class II	Active
Aristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24 Guidewire, 200cm, Standard Profile ; Aristotle 24 Guidewire, 200cm, Support Profile	K192783	FDA 510(k)	Class II	Active
Plato 17 Microcatheter	K210601	FDA 510(k)	Class II	Active
Zoom 14 Guidewire	K201760	FDA 510(k)	Class II	Active
Plato Microcath 27 Microcatheter	K121734	FDA 510(k)	Class II	Active
Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire; Aristotle Colossus Guidewire	K243938	FDA 510(k)	Class II	Active
Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard Profile, Volo 14 Guidewire, 300cm, Soft Profile, Volo 14 Guidewire, 300cm, Standard Profile	K181828	FDA 510(k)	Class II	Active
Aristotle 24 Guidewire	A24-200-003	EUDAMEDFDA UDI	Class III	Active
Aristotle 24 Guidewire	A24-200-002	EUDAMEDFDA UDI	Class III	Active
Aristotle 24 Guidewire	A24-200-001	EUDAMEDFDA UDI	Class III	Active
Aristotle 18 Guidewire	A18-200-003	EUDAMEDFDA UDI	Class III	Active

Related Companies

Authorised Representatives

Medical Technology Promedt Consulting GmbH DE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (3)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Jan 16, 2025	Z-1235-2025	—	open, classified	Due to manufacturing non-conformance that resulted in channels in the seal on the packaging pouch. As a result, this could potential create a breach in the sterile barrier.
Jan 2, 2025	Z-1234-2025	—	open, classified	Due to manufacturing non-conformance that resulted in channels in the seal on the packaging pouch. As a result, this could potential create a breach in the sterile barrier.
Feb 1, 2023	Z-1249-2023	—	open, classified	Microcatheters for embolic coil and diagnostic agent introduction to peripheral/neuro vasculature, due to manufacturing non-conformance, and due to flush, guidewire insertion and manipulation prior to placement, may have loose particles within catheter lumens that may be introduced to patients, which could cause embolic event, small vessel occlusion, and subacute to chronic inflammatory response.