FDA applicant

Novoste Puerto Rico, Inc.

Aguadilla, Puerto Rico1 decision1990–19900 recalls

FDA records 1 decision for Novoste Puerto Rico, Inc. (Aguadilla, Puerto Rico) in 1990: 1 510(k) clearance. All are in product code DYB (Introducer, Catheter). No 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 Novoste Puerto Rico, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Novoste Puerto Rico, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Novoste Puerto Rico, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Novoste Puerto Rico, 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 “Novoste”

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

Novoste Corp. 5

Novoste Puerto Rico, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Novoste”