Medcomp ( Medical Components)
Harleysville, PA, US
Medcomp ( Medical Components) appears in FDA device records in Harleysville, PA. FDA records list 13 510(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
- 13
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 13 510(k) clearances for Medcomp ( Medical Components) between 2009 and 2017. The busiest year on record is 2013, with 3. The most recent is 2017, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2009 | 1 |
| 2011 | 1 |
| 2013 | 3 |
| 2014 | 2 |
| 2015 | 1 |
| 2016 | 2 |
| 2017 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K171931 | Celerity ECG Cable Accessory Pack | LJS | Substantially Equivalent | |
| K162389 | Medcomp Vessel Dilator | DRE | Substantially Equivalent | |
| K162271 | Pro-Lock CT Safety Infusion Set | PTI | Substantially Equivalent | |
| K153238 | Dignity Dual Port | LJT | Substantially Equivalent | |
| K153246 | PTFE Super Sheath Introducer 2.1 | DYB | Substantially Equivalent | |
| K143238 | C3 Wave | LJS | Substantially Equivalent | |
| K141151 | CT MIDLINE | LJS | Substantially Equivalent | |
| K140799 | CELERITY SYSYEM | LJS | Substantially Equivalent | |
| K132177 | MEDCOMP GEN III POWER INJECTABLE PORT | LJT | Substantially Equivalent | |
| K132498 | VALVED TEARAWAY INTRODUCER GENERATION II | DYB | Substantially Equivalent | |
| K130897 | MEDCOMP VASCU-PICC WITH VALVE | LJS | Substantially Equivalent | |
| K110424 | DIGNITY MINI PORT- ATTACHABLE; DIGNITY MINI PORT- PRE ATTACHED; DIGNITY LOW PROFILE PORT- ATTACHABLE; DIGNITY LOW PROFIL | LJT | Substantially Equivalent | |
| K093309 | PRO-LINE CT (BASIC TRAY) MODEL MR28036101 | LJS | 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