Bridge Occlusion Balloon— 510(k) K153530
Substantially EquivalentSpectranetics, Inc.
FDA 510(k) clearance K153530 for Bridge Occlusion Balloon, Substantially Equivalent on 2016-02-05. Applicant: Spectranetics, Inc.. Device class: 2.
Clearance details
- Applicant
- Spectranetics, Inc.
- Product code
- Code MJN
- Device class
- Class 2
- Regulation
- 21 CFR 870.4450
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Colorado Springs, CO, US
Recent devices under product code MJN
view allMore clearances from Spectranetics, Inc.
view all- K223472 — TightRail Guardian Motorized Dilator Sheath, 9 French (575-009) +2 more
- K222837 — Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters
- K212784 — TightRail Guardian Motorized Dilator Sheath
- DEN210024 — CavaClear Laser Sheath
- K203540 — Bridge Occlusion Balloon
Adverse events under product code MJN
product code MJN- Death
- 31
- Injury
- 240
- Malfunction
- 827
- Total
- 1,098
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 K153530
K-number listed on FDA's recall record- Z-2143-2020 — Bridge Occlusion Balloon, REF 590-001, QTY 1, Sheath Compatibility 12F, Guidewire Compatibility 0.035 in, Working Length 90 cm, Balloon Outer Diameter 31 mm, Balloon Length 80 mmm, Rx ONLY, CE Marking, Sterile EO, UDI: 00813132024666
- Z-3106-2017 — Spectranetics Bridge Occlusion Balloon catheter, Sheath Compatibility 12F, Guidewire Compatibility 0.035in, Working Length 90cm, Balloon Outer Diameter 31mm, Balloon Length 80mm, Rx Only. Product Usage: It is a device used to occlude the vessel and prevent blood loss as the physician preps for surgery resulting from an SVC tear complication of a lead extraction case. It is used for temporary vessel occlusion of the superior vena cava in applications including perioperative occlusion and emergency control of hemorrhage.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K153530.
Data sourced from openFDA. This site is unofficial and independent of the FDA.