CDI(TM) H/S CUVETTE, MODIFICATION— 510(k) K915265
Substantially Equivalent3M Company
FDA 510(k) clearance K915265 for CDI(TM) H/S CUVETTE, MODIFICATION, Substantially Equivalent on 1992-01-15. Applicant: 3M Company. Device class: 2.
Clearance details
- Applicant
- 3M Company
- Product code
- Code DRY
- Device class
- Class 2
- Regulation
- 21 CFR 870.4330
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tustin, CA, US
Recent devices under product code DRY
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- K241959 — 3M Attest Super Rapid Steam Clear Challenge Pack (1492PCD) +3 more
- K241710 — 3M Attest Super Rapid Readout Biological Indicator 1492V +3 more
- K240717 — 3M Attest Rapid Readout Biological Indicator 1295 and 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E
Adverse events under product code DRY
product code DRY- Death
- 5
- Total
- 5
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 K915265
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 K915265.
Data sourced from openFDA. This site is unofficial and independent of the FDA.