Company ยท US
Lifestream Int'L, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1984 to 1997. Name variants (Inc, Corp, punctuation) are merged.
23510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GEX | Powered Laser Surgical Instrument | 7 |
| CAC | Apparatus, Autotransfusion | 2 |
| DQO | Catheter, Intravascular, Diagnostic | 1 |
| DTN | Reservoir, Blood, Cardiopulmonary Bypass | 1 |
| DTR | Heat-Exchanger, Cardiopulmonary Bypass | 1 |
| DXS | Gauge, Pressure, Coronary, Cardiopulmonary Bypass | 1 |
| FTX | Mirror, General & Plastic Surgery | 1 |
| GBZ | Catheter, Cholangiography | 1 |
| GDY | Gauze/Sponge, Internal, X-Ray Detectable | 1 |
| GEA | Cannula, Surgical, General & Plastic Surgery | 1 |
| HMW | Drape, Microscope, Ophthalmic | 1 |
| JDY | Evacuator, Vapor, Cement Monomer | 1 |
| KKX | Drape, Surgical, Antimicrobial | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 8, 1997 | K964571 | VISION CARDIOPLEGIA DELIVERY SYSTEM Lifestream Int'L, Inc. | DTR |
| Sep 11, 1996 | K962354 | DIOMED 15, 30, 60 SURGICAL DIODE LASER Lifestream Int'L, Inc. | GEX |
| May 13, 1993 | K920178 | CARDIOTOMY RESERVOIR W/20 MICRON FILITER Lifestream Int'L, Inc. | DTN |
| Mar 12, 1993 | K920618 | AUTOTRANSFUSION SUCTION SET Lifestream Int'L, Inc. | CAC |
| May 20, 1992 | K913181 | AUTOLOGOUS BLOOD PROCESSING SYSTEM Lifestream Int'L, Inc. | CAC |
| Dec 23, 1991 | K914396 | SURGI LIGHT NON-CONTACT FIBERS Lifestream Int'L, Inc. | GEX |
| Oct 31, 1991 | K912045 | TMP PRESSURE ISOLATORR, TMP PRESSURE MONITOR SYST Lifestream Int'L, Inc. | DXS |
| Apr 22, 1991 | K911523 | MODIFICATION TO MODEL 90-1460 LASER ADAPTER Lifestream Int'L, Inc. | GEX |
| Mar 29, 1991 | K910726 | LIGHT-TOUCH AND SURGI LIGHT FIBERS Lifestream Int'L, Inc. | GEX |
| Feb 1, 1991 | K904491 | TMP LEFT ATRIAL PRESSURE CATH CAT.# 100-00X-000 Lifestream Int'L, Inc. | DQO |
| Oct 26, 1990 | K903709 | SURGIMEDICS, SLP LAPAROSCOPIC CHOLANGIOGRAM CATH Lifestream Int'L, Inc. | GBZ |
| May 26, 1989 | K891909 | LIGHT-TOUCH/GS 905250 ND:YAG LASER MICRO PRO ENDOS Lifestream Int'L, Inc. | GEX |
| May 23, 1989 | K891130 | LIGHT-TOUCH LAPAROSCOPIC MODEL 905200 FIBEROPTIC Lifestream Int'L, Inc. | GEX |
| May 28, 1987 | K871068 | DISPOSABLE LASER PROTECTIVE DRAPE FOR CO2 LASER Lifestream Int'L, Inc. | KKX |
| Apr 1, 1987 | K870790 | REFLECTIVE MIRROR/CO2 LASER SURG CAT. #902002-000 Lifestream Int'L, Inc. | FTX |
| Nov 17, 1986 | K862815 | LASER SURGICAL ROD Lifestream Int'L, Inc. | GEX |
| Oct 14, 1986 | K863089 | DISPOSABLE LASER SPONGE SURGIMEDICS, 902001-000 Lifestream Int'L, Inc. | GDY |
| Sep 12, 1986 | K863241 | LASER ASSISTED SURGICAL LAPAROSCOPY KITS Lifestream Int'L, Inc. | |
| Sep 9, 1986 | K863293 | DISPOSABLE SUCTION CANNULA NO. 902008-000 Lifestream Int'L, Inc. | GEA |
| Aug 21, 1986 | K862213 | PRESSURE CONTROL VALVE & TUBING CAT. NO. 83-1010 Lifestream Int'L, Inc. | |
| Aug 14, 1986 | K862954 | LASER PLUME FILTERS Lifestream Int'L, Inc. | |
| Jul 23, 1986 | K862509 | CHARCOAL LASER SMOKE FILTER CATALOG NO. 901103-000 Lifestream Int'L, Inc. | JDY |
| Oct 26, 1984 | K843890 | CUSTOM INSTRUMENT DRAPE Lifestream Int'L, Inc. | HMW |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||