SMITH MEDICAL PEEL-AWAY SHEATH INTRODUCERS— 510(k) K112407
Substantially EquivalentSmiths Medical MD, Inc.
FDA 510(k) clearance K112407 for SMITH MEDICAL PEEL-AWAY SHEATH INTRODUCERS, Substantially Equivalent on 2012-02-09. Applicant: Smiths Medical MD, Inc.. Device class: 2.
Clearance details
- Applicant
- Smiths Medical MD, 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
- St. Paul, MN, US
Recent devices under product code DYB
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view all- K111386 — MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP, PHARMGUARD TOOLBOX 2 MEDICATION SAFETY SOFTWARE AND SUPPORTED SYRINGES (PSS)
- K101180 — GRIPPER MICRO BLUNT CANNULA, NON-CORING SAFETY NEEDLE (GRIPPER MICRO NEEDLE) MODEL: 21-3253-24, 21-3258-24, 21-3262-24,
- K091181 — LOCKBOX FOR USE WITH MEDFUSION 3000 SERIES PUMPS
- K082783 — CADD -SOLIS MEDICATION SAFETY SOFTWARE: ADMINISTRATOR AND POINT-OF-CARE
- K081156 — CADD MEDICATION CASSETTE RESERVOIR
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.