MEDTRONIC VASCULAR CATHETER, MULTI LUMEN MODELS 84640, 84652— 510(k) K961336
Substantially EquivalentMedtronic PS Medical
FDA 510(k) clearance K961336 for MEDTRONIC VASCULAR CATHETER, MULTI LUMEN MODELS 84640, 84652, Substantially Equivalent on 1996-07-18. Applicant: Medtronic PS Medical. Device class: 2.
Clearance details
- Applicant
- Medtronic PS Medical
- Product code
- Code LJS
- Device class
- Class 2
- Regulation
- 21 CFR 880.5970
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Goleta, CA, US
Recent devices under product code LJS
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- K252373 — BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology +6 more
- K252792 — PM2 System with ECGuide Connector
- K243458 — HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301) +5 more
- K251212 — Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM)
More clearances from Medtronic PS Medical
view all- K012052 — MEDTRONIC PS MEDICAL STRATA VALVE, MODELS 42855, 42865, 92865, 92855
- K010361 — MEDTRONIC PS MEDICAL INVISX CRANIAL FIXATION SYSTEM, MODEL 60100-60900
- K010487 — BIPOLAR PENCIL, MODEL 3901-002, 3900-002
- K010341 — MEDTRONIC PS MEDICAL MURPHYSCOPE, MODELS 2125-032, 2125033,2125-042, 2125-043, 2125-157, 2125-158,2125-161 2125-162,,
- K003914 — MEDTRONIC PS MEDICAL NEUROPEN ENDOSCOPE AND OPTICAL ACCESSORIES
Adverse events under product code LJS
product code LJS- Death
- 31
- Injury
- 2,791
- Malfunction
- 18,374
- Other
- 5
- Total
- 21,201
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.