FDA Device Intelligence
Home › ACIST MEDICAL SYSTEMS, INC. › ACIST Navvus®II Catheter

ACIST Navvus®II Catheter

ACIST MEDICAL SYSTEMS, INC. · Model 016675 · UDI-DI 10841716102483

OBI Prescription
1
510(k) clearances
22
Adverse events (1 deaths)
1
Recalls
3
Facilities

Description

Navvus II Catheter, p/n 701711-002

Recalls

DateFirmReason
2014-03-13Merit Medical Systems, Inc.The products are labeled as sterile but were not sterilized.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.