← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

DQY — Catheter, Percutaneous

DEVICE CLASS
Class II
REGULATION
21 CFR 870.1250
MEDICAL SPECIALTY
Cardiovascular
REVIEW PANEL
CV
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
32
510(K)/PMA CLEARANCES
510k: 32
0
RECALL ENTRIES

Recent clearances

K261825Abbott · 510k2026-07-02
K261631Abbott Medical · 510k2026-06-17
K260289Balosmark, Inc. · 510k2026-06-05
K260993Abbott · 510k2026-04-24
K253361OrbusNeich Medical (Shenzhen) Co., Ltd. · 510k2026-04-10
K260499ABBOTT MEDICAL · 510k2026-03-13
K253409Medtronic, Inc. · 510k2025-12-19
K252417ABBOTT MEDICAL · 510k2025-12-17

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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