MEDRAD MARK 7 ARTERION INJECTION SYSTEM / SYRINGE, TWIST & GO SYRINGE— 510(k) K132928
Substantially EquivalentMedrad, Inc. / Bayer Medical Care, Inc.
FDA 510(k) clearance K132928 for MEDRAD MARK 7 ARTERION INJECTION SYSTEM / SYRINGE, TWIST & GO SYRINGE, Substantially Equivalent on 2014-01-23. Applicant: Medrad, Inc. / Bayer Medical Care, Inc.. Device class: 2.
Clearance details
- Applicant
- Medrad, Inc. / Bayer Medical Care, Inc.
- Product code
- Code DXT
- Device class
- Class 2
- Regulation
- 21 CFR 870.1650
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Indianola, PA, US
Recent devices under product code DXT
view all- K252652 — Disposable Syringes with Accessories for Power Injectors (7+ models)
- K252638 — VeraPro S100 Multi-Use Syringe (018808) +4 more
- K252653 — ACIST Pro Diagnostic System (019304) +5 more
- K253048 — High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube
- K251788 — Extension tube
More clearances from Medrad, Inc. / Bayer Medical Care, Inc.
view allAdverse events under product code DXT
product code DXT- Death
- 39
- Injury
- 242
- Malfunction
- 463
- Other
- 3
- Total
- 747
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 K132928
K-number listed on FDA's recall record- Z-0199-2022 — The MEDRAD Twist & Go Disposable Syringe 150 mL with Quick Fill Tube is a syringe made from a clear polycarbonate material and is an accessory to the MEDRAD Mark 7 Arterion Injection System. It is designed to be loaded into the injector head of the injection system.
- Z-2775-2015 — Angiographic Injector. Medrad Mark 7 Arterion Injection System, which utilizes Software Version SW 005.006_SH; to be used specifically for the purposes of injecting contrast medium and common flushing solutions into humans for angiographic studies.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K132928.
Data sourced from openFDA. This site is unofficial and independent of the FDA.