FDA applicant

Silk Road Medical, Inc.

Sunnyvale, CA6 decisions2013–20232 recalls

FDA records 6 decisions for Silk Road Medical, Inc. (Sunnyvale, CA) from 2013 to 2023: 6 510(k) clearances. Most are in product codes NTE (Temporary Carotid Catheter For Embolic Capture) and DQY (Catheter, Percutaneous). Its devices cite 7 predicates, 3 of them its own earlier devices. 2 recalls are linked to its devices, 2 Class I.

FDA’s records also spell it “Silk Road Medical”.

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 Silk Road Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2013high 2 (2015) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

2in 2026

2013high 2 (2026) · low 0 (2013)2026

Class I Class II/III not classified

FIG. 1 — Silk Road Medical, Inc. by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Other applicant names beginning “Silk”

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

Silk Holdings, Inc. 1 Silk*Skin Care Co. 1 Silk'N Beauty, Ltd. 1

Silk Road Medical, Inc.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Silk”