REMINGTON MEDICAL DISPOS TEAR-AWAY VASC INTRO SET— 510(k) K932370
Substantially EquivalentRemington Medical, Inc.
FDA 510(k) clearance K932370 for REMINGTON MEDICAL DISPOS TEAR-AWAY VASC INTRO SET, Substantially Equivalent on 1993-11-09. Applicant: Remington Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Remington Medical, Inc.
- Product code
- Code DYB
- Device class
- Class 2
- Regulation
- 21 CFR 870.1340
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Atlanta, GA, US
Recent devices under product code DYB
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- K241583 — VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-CP-01, VC-CH-01) +1 more
- K211589 — VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger
- K212065 — VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger
- K191315 — Remington Medical, Inc. Automatic Cutting Needle (NAC)
Adverse events under product code DYB
product code DYB- Death
- 808
- Injury
- 5,922
- Malfunction
- 16,516
- Other
- 5
- Total
- 23,251
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.