510(k) Report

510(k) · Cleared

Cleared

Medtronic PS Medical Rivas Vascular Catheter Repair Kit

K970341510(k) TraditionalCleared Apr 23, 199784-day review

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medtronic PS Medical · LIS (no longer in FDA’s product-code list)

Cleared on Apr 23, 1997 after an 84-day review. The FDA summary names its predicate without a number.

Decided
Apr 23, 1997
Review
84 days
Product code
LIS
Recalls
None
Predicates
0

The FDA summary names its predicate without a number.

FIG. 1 — Lineage of K970341Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*—Bard Davol Repair Kit
Named without a submission number
—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

More from Medtronic PS Medical

14 FDA decisions under this applicant name. See the company

  • K012052Medtronic PS Medical Strata Valve, Models 42855, 42865, 92865, 92855Medtronic PS Medical · 2002
  • K010361Medtronic PS Medical Invisx Cranial Fixation System, Model 60100-60900Medtronic PS Medical · 2001
  • K010487Bipolar Pencil, Model 3901-002, 3900-002Medtronic PS Medical · 2001
  • K010341Medtronic PS Medical Murphyscope, Models 2125-032, 2125033,2125-042, 2125-043, 2125-157, 2125-158,2125-161…Medtronic PS Medical · 20012 recalls
  • K003914Medtronic PS Medical Neuropen Endoscope and Optical AccessoriesMedtronic PS Medical · 2001

https://510kreport.com/device/K970341 · printed Nov 6, 2026

Cite this page

510(k) Report. “K970341: Medtronic PS Medical Rivas Vascular Catheter Repair Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970341

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Page last updated Nov 3, 2026