Company ยท US
Jelco Laboratories
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 1979. Name variants (Inc, Corp, punctuation) are merged.
26510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 5 |
| FPA | Set, Administration, Intravascular | 4 |
| FPB | Filter, Infusion Line | 4 |
| GIM | Tubes, Vacuum Sample, With Anticoagulant | 3 |
| GAA | Needle, Aspiration And Injection, Disposable | 2 |
| BSN | Filter, Conduction, Anesthetic | 1 |
| CBT | Arterial Blood Sampling Kit | 1 |
| DQO | Catheter, Intravascular, Diagnostic | 1 |
| FRL | Fiber, Medical, Absorbent | 1 |
| GBJ | Prosthesis, Adhesive, External | 1 |
| GCB | Needle, Catheter | 1 |
| JCY | Catheter, Infusion | 1 |
| KMK | Device, Intravascular Catheter Securement | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 2, 1979 | K791918 | JELCO WINGED INTRAVASCULAR CATHETER Jelco Laboratories | FOZ |
| Sep 12, 1979 | K791372 | JELCO & KVO CATHETER PLACEMENT UNIT Jelco Laboratories | JCY |
| Jun 27, 1979 | K790967 | CATHETER METAL HUB/RADIOPAQUE Jelco Laboratories | FOZ |
| Jun 11, 1979 | K790968 | CATHETER METAL HUB/NONRADIOPAQUE Jelco Laboratories | FOZ |
| Apr 30, 1979 | K790471 | JELCO* DISC FILTER-0.2 MICRON Jelco Laboratories | FPB |
| Feb 26, 1979 | K790186 | PROTECTIVSTABILIZER Jelco Laboratories | GBJ |
| Feb 1, 1979 | K790107 | CATHETER TUBING MODIFICATION Jelco Laboratories | DQO |
| Feb 1, 1979 | K790079 | NEEDLE, BLOOD COLLECTING Jelco Laboratories | GAA |
| Dec 11, 1978 | K781857 | TRAY, ARTERIAL BLOOD GAS SAMPLING Jelco Laboratories | CBT |
| Aug 23, 1978 | K780896 | NEEDLES, DESIGN CHANGE, IV CATHETERS Jelco Laboratories | GCB |
| May 9, 1978 | K780519 | FILTER TUBE Jelco Laboratories | BSN |
| Dec 2, 1977 | K771874 | J-VAC VACUUM TUBE Jelco Laboratories | GIM |
| Oct 25, 1977 | K771536 | AIR VENT FILTER NEEDLE, 0.45 Jelco Laboratories | FPB |
| Oct 13, 1977 | K771827 | INTRAVENOUS FILTER W/FLASH BULB Jelco Laboratories | FPB |
| Oct 13, 1977 | K771826 | INTRAVENOUS FILTER W/AUTO AIR VENT Jelco Laboratories | FPB |
| Oct 13, 1977 | K771381 | IV CATHETER HUB Jelco Laboratories | FOZ |
| Oct 4, 1977 | K771551 | I.V. PREP & CARE KIT Jelco Laboratories | FRL |
| May 23, 1977 | K770589 | FILTER, INTRAVENOUS W/AUTO AIR VENT Jelco Laboratories | FPA |
| Mar 14, 1977 | K770119 | I.V. LOK TM Jelco Laboratories | KMK |
| Aug 11, 1976 | K760319 | KIT, CATHETER Jelco Laboratories | FOZ |
| Aug 9, 1976 | K760022 | NEEDLE, FILTER Jelco Laboratories | GAA |
| Jul 20, 1976 | K760019 | VACUUM TUBES, PEDIATRIC SIZES (J-VAC) Jelco Laboratories | GIM |
| Jul 20, 1976 | K760018 | VACUUM TUBES, STERILE (J-VAC) Jelco Laboratories | GIM |
| Jul 16, 1976 | K760111 | FILTER, I.V., WITH FLASH BULB (#4701) Jelco Laboratories | FPA |
| Jul 16, 1976 | K760110 | FILTER, I.V. (#4700) Jelco Laboratories | FPA |
| Jul 16, 1976 | K760103 | CAP, INJECTION (#4600) Jelco Laboratories | FPA |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||