CONCHASMART COLUMN— 510(k) K141940
Substantially EquivalentTeleflex, Inc.
FDA 510(k) clearance K141940 for CONCHASMART COLUMN, Substantially Equivalent on 2014-11-24. Applicant: Teleflex, Inc.. Device class: 2.
Clearance details
- Applicant
- Teleflex, Inc.
- Product code
- Code BTT
- Device class
- Class 2
- Regulation
- 21 CFR 868.5450
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Durham, NC, US
Recent devices under product code BTT
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- K140110 — FLEXTIP PLUS EPIDURAL CATHETER; FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SET
- K140556 — CONCHASMART BREATHING CIRCUIT
- K131912 — CONCHATHERM NEPTUNE HEATED HUMIDIFIER, COMFORT FLO HUMIDIFICATION SYSTEM, CONCHASMART COLUMN
- K123974 — PERCUTANEOUS INTRODUCER KIT
Adverse events under product code BTT
product code BTT- Death
- 60
- Injury
- 152
- Malfunction
- 7,232
- Other
- 2
- Total
- 7,446
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.