Medsource International, LLC
Indianapolis, IN, US
Medsource International, LLC appears in FDA device records in Indianapolis, IN. FDA records list 10 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 10
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 10 510(k) clearances for Medsource International, LLC between 2008 and 2023. The busiest year on record is 2014, with 3. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2008 | 2 |
| 2012 | 1 |
| 2014 | 3 |
| 2015 | 2 |
| 2016 | 1 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K223788 | The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter | FOZ | Substantially Equivalent | |
| K161779 | MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV Catheter | FOZ | Substantially Equivalent | |
| K150611 | MedSource ClearSafe Safety IV Catheter | FOZ | Substantially Equivalent | |
| K150333 | MedSource Sharps Dart | MMK | Substantially Equivalent | |
| K140442 | MEDSOURCE SELECTABLE IV SET | LHI | Substantially Equivalent | |
| K140402 | MEDSOURCE IV ADMINISTRATION SET 72 MEDSOURCE IV ADMINISTRATION SET, NEEDLELESS MALE ADAPTER, MEDSOURCE IV EXTENSION SET | LHI | Substantially Equivalent | |
| K131555 | MEDSOURCE IV SAFETY CATHETER | FOZ | Substantially Equivalent | |
| K120424 | MEDSOURCE IV ADMINSTRATION SET | LHI | Substantially Equivalent | |
| K080339 | MEDSOURCE ENDOTRACHEAL TUBE (WITH AND WITHOUT CUFF) | BTR | Substantially Equivalent | |
| K081516 | MEDSOURCE CPR MASK WITH & WITHOUT OXYGEN PORT | CBP | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain