VACUTAINER BRAND PLUS TUBE WITH EDTA ANTICOAGULANT(MULTIPLE)— 510(k) K971449
Substantially EquivalentBecton Dickinson Vacutainer Systems
FDA 510(k) clearance K971449 for VACUTAINER BRAND PLUS TUBE WITH EDTA ANTICOAGULANT(MULTIPLE), Substantially Equivalent on 1997-06-17. Applicant: Becton Dickinson Vacutainer Systems. Device class: 2.
Clearance details
- Applicant
- Becton Dickinson Vacutainer Systems
- Product code
- Code GIM
- Device class
- Class 2
- Regulation
- 21 CFR 862.1675
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Franklin Lake, NJ, US
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More clearances from Becton Dickinson Vacutainer Systems
view all- K002456 — MICROTAINER BRAND SODIUM FLUORIDE/EDTA TUBE WITH MICROGARD CLOSURE, MODEL 365992
- K991702 — MICROTAINER BRAND CHEMISTRY TUBES WITH MICROGARD CLOSURE, MODEL 365965, 365985, 365963, 365967, 36578
- K991088 — VACUTAINER BRAND MULTIPLE SAMPLE LUER ADAPTER, BLOOD COLLECTION SETS AND SAFETY-LOK BLOOD COLLECTION, SAFETY BLOOD COLLE
- K991120 — VACUTAINER BRAND CTAD TUBE (MULTIPLE)
- K982541 — VACUTAINER BRAND ECLIPSE BLOOD COLLECTION NEEDLE, MODELS# 368607 & 368608
Adverse events under product code GIM
product code GIM- Malfunction
- 1,325
- Total
- 1,325
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 K971449
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 K971449.
Data sourced from openFDA. This site is unofficial and independent of the FDA.