The following data is part of a premarket notification filed by Horizon Medical Products, Inc. with the FDA for Lifeguard Safety Infusion Set.
| Device ID | K013871 |
| 510k Number | K013871 |
| Device Name: | LIFEGUARD SAFETY INFUSION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | HORIZON MEDICAL PRODUCTS, INC. 1 HORIZON WAY Manchester, GA 31816 |
| Contact | Patricia D Jones |
| Correspondent | Patricia D Jones HORIZON MEDICAL PRODUCTS, INC. 1 HORIZON WAY Manchester, GA 31816 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-21 |
| Decision Date | 2002-03-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50849884001131 | K013871 | 000 |
| 30849884003902 | K013871 | 000 |
| 38498840006246 | K013871 | 000 |
| 38498840006253 | K013871 | 000 |
| 38498840006260 | K013871 | 000 |
| 38498840006277 | K013871 | 000 |
| 38498840006284 | K013871 | 000 |
| 38498840006291 | K013871 | 000 |
| 38498840006307 | K013871 | 000 |
| 38498840006314 | K013871 | 000 |
| 38498840006321 | K013871 | 000 |
| 38498840006338 | K013871 | 000 |
| 30849884003896 | K013871 | 000 |
| 30849884003889 | K013871 | 000 |
| 50849884003876 | K013871 | 000 |
| 50849884001186 | K013871 | 000 |
| 30849884001922 | K013871 | 000 |
| 50849884003784 | K013871 | 000 |
| 50849884003791 | K013871 | 000 |
| 50849884003807 | K013871 | 000 |
| 50849884003814 | K013871 | 000 |
| 30849884003827 | K013871 | 000 |
| 30849884003834 | K013871 | 000 |
| 50849884003845 | K013871 | 000 |
| 30849884003858 | K013871 | 000 |
| 30849884003865 | K013871 | 000 |
| 38498840006345 | K013871 | 000 |
| 38498840006352 | K013871 | 000 |
| H787LG20505 | K013871 | 000 |
| H787LG2050NY5 | K013871 | 000 |
| H787LG20755 | K013871 | 000 |
| H787LG2075NY5 | K013871 | 000 |
| H787LG221005 | K013871 | 000 |
| H787LG22100NY5 | K013871 | 000 |
| H787LG22505 | K013871 | 000 |
| H787LG2250NY5 | K013871 | 000 |
| H787LG22755 | K013871 | 000 |
| H787LG2275NY5 | K013871 | 000 |
| H787LGV2075Y5 | K013871 | 000 |
| H787LG20150NY5 | K013871 | 000 |
| H787LG201505 | K013871 | 000 |
| H787LG20100NY5 | K013871 | 000 |
| 38498840006369 | K013871 | 000 |
| 58498840006370 | K013871 | 000 |
| 38498840006383 | K013871 | 000 |
| 58498840006394 | K013871 | 000 |
| 58498840006400 | K013871 | 000 |
| 38498840006413 | K013871 | 000 |
| H787LG191005 | K013871 | 000 |
| H787LG19100NY5 | K013871 | 000 |
| H787LG19755 | K013871 | 000 |
| H787LG1975NY5 | K013871 | 000 |
| H787LG201005 | K013871 | 000 |
| H787LGV22755 | K013871 | 000 |