SHERPA SHERPA II AND ASCENT CORONARY GUIDING CATHETERS— 510(k) K944668
Substantially EquivalentMedtronics Interventional Vascular
FDA 510(k) clearance K944668 for SHERPA SHERPA II AND ASCENT CORONARY GUIDING CATHETERS, Substantially Equivalent on 1995-03-03. Applicant: Medtronics Interventional Vascular. Device class: 2.
Clearance details
- Applicant
- Medtronics Interventional Vascular
- Product code
- Code DQY
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Danvers, MA, US
Recent devices under product code DQY
view allMore clearances from Medtronics Interventional Vascular
view all- K990707 — MEDTRONIC 5F & 9F ZUMA GUIDING CATHETERS
- K980973 — MEDTRONIC ANGIOGRAPHIC CATHETER
- K982883 — MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER
- K981198 — MEDTRONIC ZUMA GUIDING CATHETER
- K972944 — MEDTRONIC MUSTANG SUPER FLOPPY GUIDE WIRE/FLOPPY GUIDE WIRE/INTERMEDIATE GUIDE WIRE/STANDARD GUIDE WIRE/EXTRA SUPPORT
Adverse events under product code DQY
product code DQY- Death
- 464
- Injury
- 4,489
- Malfunction
- 13,721
- Other
- 2
- Total
- 18,676
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.