INDEFLATOR PLUS 30/PLUS 30 PRIORITY PACK9WITH THE.096 OR.115 ROTATING HEMOSTATIC VALVE)— 510(k) K962495
Substantially EquivalentAdvanced Cardiovascular Systems, Inc.
FDA 510(k) clearance K962495 for INDEFLATOR PLUS 30/PLUS 30 PRIORITY PACK9WITH THE.096 OR.115 ROTATING HEMOSTATIC VALVE), Substantially Equivalent on 1996-09-12. Applicant: Advanced Cardiovascular Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Advanced Cardiovascular Systems, Inc.
- Product code
- Code MAV
- Device class
- Class 2
- Regulation
- 21 CFR 870.1650
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Clara, CA, US
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More clearances from Advanced Cardiovascular Systems, Inc.
view all- K012534 — HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
- K000550 — OTW MEGALINK SDS BILIARY STENT SYSTEM
- K994229 — VERIPATH PERIPHERAL GUIDING CATHETER
- K992169 — ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE
- K990867 — RX HERCULINK 14 BILIARY STENT SYSTEM, MODEL 1005126-18,1005128-18,1005130-18,1005132-18,1005134-18,1005136-18,1005138-18
Adverse events under product code MAV
product code MAV- Malfunction
- 1,433
- Total
- 1,433
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 K962495
K-number listed on FDA's recall record- Z-0924-2022 — INDEFLATOR Plus 30 - REF 1000183 WPL2122277-01 (2019-03-01)
- Z-0925-2022 — Plus 30 Priority Pack w/.096 RHV - REF 1000183 WPL2122277-01 (20-03-01) Plus 30 Priority Pack w/.115 RHV - REF 1000185-115 WPL2122279-01 (2019-03-01)
- Z-0960-2019 — PLUS 30 PRIORITY PACK Accessory Kit Product Usage: Is recommended for use during vascular procedures in conjunction with interventional and / or diagnostic devices (e.g., balloon dilatation catheters, atherectomy devices, stent delivery systems, intravascular ultrasound devices).
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K962495.
Data sourced from openFDA. This site is unofficial and independent of the FDA.