Opticross 35 15 MHz Peripheral Imaging Catheter— 510(k) K200733

Clearance details

Applicant

Boston Scientific Corporation

Product code

Code ITX

Device class

Class 2

Regulation

21 CFR 892.1570

Advisory panel

Radiology

Date received

2020-03-20

Decision date

2020-04-17

Decision

Substantially Equivalent

Clearance type

Special

Location

Maple Grove, MN, US

• K261170 — BA-004CC2026-08-12
• K254143 — EM-TECH Passive Ultrasound Probe Strap2026-08-10
• K260161 — SmartGuide Disposable Guides and Grids2026-07-30
• K262474 — ND Needle Guidance System2026-07-27
• K261014 — Accuro® 3S Needle Guide Kit2026-07-24

• K262151 — SpaceOAR Flex System2026-09-11
• K261153 — LithoVue Elite Digital Flexible Ureteroscope System2026-08-26
• K261915 — Navigator Flex Ureteral Access Sheath Set2026-08-04
• K261488 — OBSIDIO Conformable Embolic2026-07-24
• K262165 — FARADRIVE Steerable Sheath (M004PF21M402)2026-07-24

Death

6

Injury

137

Malfunction

2,036

Total

2,179

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0181-2021 — Opticross 35 15 MHz Peripheral Imaging Catheter 8F (2.74 mm) X 105 cm Expiration Date June 8th 2021 - July 22nd 2021 Material Number (UPN) # H7493932800350 UDI # 08714729984542 Lot #25754545; 25852104; 2582106; 25856700 Product Usage: intended for ultrasound examination of peripheral vascular pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.Class II·Terminated·Boston Scientific Corporation·20200824

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K200733.