OPTICROSS 40 MHZ CORONARY IMAGING CATHETER— 510(k) K123621
Substantially EquivalentBoston Scientific Corp
FDA 510(k) clearance K123621 for OPTICROSS 40 MHZ CORONARY IMAGING CATHETER, Substantially Equivalent on 2013-04-15. Applicant: Boston Scientific Corp. Device class: 2.
Clearance details
- Applicant
- Boston Scientific Corp
- Product code
- Code OBJ
- Device class
- Class 2
- Regulation
- 21 CFR 870.1200
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fremont, CA, US
Recent devices under product code OBJ
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view all- K243245 — IceSeed 1.5 CX Straight Needle (H7493968333170) +2 more
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- K152853 — WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic Biliary
- K150692 — AXIOS Stent with Electrocautery Enhanced Delivery System
- K150303 — XXL Vascular Balloon Dilatation Catheter
Adverse events under product code OBJ
product code OBJ- Death
- 38
- Injury
- 634
- Malfunction
- 3,453
- Total
- 4,125
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K123621
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K123621.
Data sourced from openFDA. This site is unofficial and independent of the FDA.