PEEL AWAY & SPLIT SHEATH PERCU CATH INTRODUCER SET— 510(k) K860307
Substantially EquivalentTeleflex, Inc.
FDA 510(k) clearance K860307 for PEEL AWAY & SPLIT SHEATH PERCU CATH INTRODUCER SET, Substantially Equivalent on 1986-05-20. Applicant: Teleflex, Inc.. Device class: 2.
Clearance details
- Applicant
- Teleflex, 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
- Jeffrey, NH, US
Recent devices under product code DYB
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- K140110 — FLEXTIP PLUS EPIDURAL CATHETER; FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SET
- K141940 — CONCHASMART COLUMN
- K140556 — CONCHASMART BREATHING CIRCUIT
- K131912 — CONCHATHERM NEPTUNE HEATED HUMIDIFIER, COMFORT FLO HUMIDIFICATION SYSTEM, CONCHASMART COLUMN
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.