Sheath Introducer— 510(k) K150932
Substantially EquivalentBioteque Corp.
FDA 510(k) clearance K150932 for Sheath Introducer, Substantially Equivalent on 2016-07-22. Applicant: Bioteque Corp.. Device class: 2.
Clearance details
- Applicant
- Bioteque Corp.
- Product code
- Code DRE
- Device class
- Class 2
- Regulation
- 21 CFR 870.1310
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Taipei, TW
Recent devices under product code DRE
view allMore clearances from Bioteque Corp.
view all- K102633 — BIOTEQ ANGIOGRAPHIC CATHETER
- K033862 — BIOTEQ PIGTAIL DRAINAGE CATHETER SET (ONE STEP TYPE) WITH OR WITHOUT SAFETY STRING LOCK
- K033210 — BIOTEQ DOUBLE PIGTAIL URETERAL STENT SET
- K032292 — BIOTEQUE A.V. FISTULA NEEDLE SET WITH SAFETY FLEX
- K013634 — BIOTEQUE 3 IN 1 HEMODIALYSIS BLOOD TUBING PACK
Adverse 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.