QUICKDRAW VENOUS CANNULA— 510(k) K981995
Substantially EquivalentHeartport, Inc.
FDA 510(k) clearance K981995 for QUICKDRAW VENOUS CANNULA, Substantially Equivalent on 1999-04-20. Applicant: Heartport, Inc.. Device class: 2.
Clearance details
- Applicant
- Heartport, Inc.
- Product code
- Code DWF
- Device class
- Class 2
- Regulation
- 21 CFR 870.4210
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Redwood City, CA, US
Recent devices under product code DWF
view allMore clearances from Heartport, Inc.
view all- K994243 — DIRECTFLOW KIT, 24 FR, SOFTCLAMP KIT, 24FR, STRAIGHTSHOT KIT, 23 FR, STRAIGHT TIP, STRAIGHTSHOT KIT, 23 FR, ANGLED TIP
- K990772 — DIRECTFLOW ARTERIAL CANNULA
- K981009 — HEARTPORT ENDOPULMONARY VENT CATHETER
- K974736 — HEARTPORT DIRECT AORTIC RETURN CANNULA WITH INTRODUCER
- K974175 — HEARTPORT ENDOAORTIC CLAMP CATHETER
Adverse events under product code DWF
product code DWF- Death
- 106
- Injury
- 386
- Malfunction
- 2,323
- Total
- 2,815
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 K981995
K-number listed on FDA's recall record- Z-0800-2020 — QuickDraw Venous Cannula, REF: QD22, UDI: 00690103182699; and REF: QD25, UDI: 00690103182705
- Z-1542-2013 — QuickDraw Venous Cannula with Insertion Kit. ThruPort Systmes. Models QD22 (22 Fr) and QD25 (25 Fr). The product is packaged sterile and non-pyrogenic in a sealed, peel-type pouch. Two pouches (cannula and accessories) go into one shelf carton. One shelf carton goes in one shipper carton. Use of the QuickDraw venous cannula is indicated for patients undergoing cardiopulmonary bypass. The QuickDraw venous cannula serves to drain non-oxygenated blood from the venae cavae or right atrium during cardiopulmonary bypass. The product is packaged sterile and nona¿ pyrogenic in a sealed, peel-type pouch.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K981995.
Data sourced from openFDA. This site is unofficial and independent of the FDA.