Coaxial Dilator Set (Micro-Introducer)— 510(k) K172487
UnknownGalt Medical Corp.
FDA 510(k) clearance K172487 for Coaxial Dilator Set (Micro-Introducer), Unknown on 2017-10-16. Applicant: Galt Medical Corp.. Device class: 2.
Clearance details
- Applicant
- Galt Medical Corp.
- Product code
- Code DRE
- Device class
- Class 2
- Regulation
- 21 CFR 870.1310
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Traditional
- Location
- Garland, TX, US
Recent devices under product code DRE
view allMore clearances from Galt Medical Corp.
view allAdverse events under product code DRE
product code DRE- Death
- 100
- Injury
- 832
- Malfunction
- 597
- Other
- 3
- Total
- 1,532
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 K172487
K-number listed on FDA's recall record- Z-2561-2018 — 1) TVS LPA, Sterile EO, Rx Only, Catalog #: a) KIT-071-01; b) KIT-071-03; c) KIT-071-10; d) KIT-071-11; 2) Enhance Transcarotid/Peripheral Access Kit, Sterile EO, Rx Only, Catalog #: a) KIT-075-02; b) KIT-075-03
- Z-2564-2018 — TVS LPA, Catalog #: DIL-059-00
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K172487.
Data sourced from openFDA. This site is unofficial and independent of the FDA.