Tearaway Introducer Sheath, MicroSlide Tearaway Introducer— 510(k) K153533
Substantially EquivalentGalt Medical Corp.
FDA 510(k) clearance K153533 for Tearaway Introducer Sheath, MicroSlide Tearaway Introducer, Substantially Equivalent on 2016-07-05. Applicant: Galt Medical Corp.. Device class: 2.
Clearance details
- Applicant
- Galt Medical Corp.
- 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
- Garland, TX, US
Recent devices under product code DYB
view allMore clearances from Galt Medical Corp.
view allAdverse 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 →
Recalls naming K153533
K-number listed on FDA's recall record- Z-1968-2023 — Tearaway Introducer Kit, REF: KIT-010-12, KIT-010-17, KIT-900-16
- Z-1969-2023 — Tearaway Introducer Set, REF: INT-028-27, INT-105-25, INT-106-09, INT-106-12, INT-106-17, DSS-007-04, DSS-007-05, DSS-010-065, DSS-012-07 (bulk)
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K153533.
Data sourced from openFDA. This site is unofficial and independent of the FDA.