FDA applicant

Abbott Vascular-Vascular Solutions

Santa Clara, CA6 decisions2008–20091 recall

FDA records 6 decisions for Abbott Vascular-Vascular Solutions (Santa Clara, CA) from 2008 to 2009: 6 510(k) clearances. Most are in product codes NTE (Temporary Carotid Catheter For Embolic Capture) and LIT (Catheter, Angioplasty, Peripheral, Transluminal). Its devices cite 8 predicates, 0 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Abbott Vascular-Vascular Solutions’s devices, and how often a recall has named them.

FDA decisions per year

2in 2009

2008high 4 (2008) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

1in 2009

2008high 1 (2009) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Abbott Vascular-Vascular Solutions by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Abbott Vascular-Vascular Solutions’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Abbott”

FDA records each applicant name separately; these may or may not be the same firm.

Abbott Laboratories 920 Abbott Medical 92 Abbott Vascular 64 Abbott Diabetes Care, Inc. 42 Abbott Molecular, Inc. 33 Abbott Diagnostics 28 Abbott Point of Care, Inc. 22 Abbott Medical Optics, Inc. 16 Abbott Mfg., Inc. 14 Abbott 14 Abbott Spine, Inc. 13 Abbott Diagnostics Scarborough, Inc. 8

Abbott Vascular-Vascular Solutions

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Other applicant names beginning “Abbott”