REMINGTON MEDICAL DISPOSABLE EXTENSION CABLE FAS-LOC FL-601— 510(k) K940467
Substantially EquivalentRemington Medical, Inc.
FDA 510(k) clearance K940467 for REMINGTON MEDICAL DISPOSABLE EXTENSION CABLE FAS-LOC FL-601, Substantially Equivalent on 1994-11-01. Applicant: Remington Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Remington Medical, Inc.
- Product code
- Code DTE
- Device class
- Class 2
- Regulation
- 21 CFR 870.3600
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Atlanta, GA, US
Recent devices under product code DTE
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- K212065 — VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger
- K191315 — Remington Medical, Inc. Automatic Cutting Needle (NAC)
Adverse events under product code DTE
product code DTE- Death
- 18
- Injury
- 247
- Malfunction
- 4,603
- Total
- 4,868
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.