Lifestream Int'L, Inc.
Sugar Land, TX, US
Lifestream Int'L, Inc. appears in FDA device records in Sugar Land, TX. FDA records list 23 510(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
- 23
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 23 510(k) clearances for Lifestream Int'L, Inc. between 1984 and 1997. The busiest year on record is 1986, with 7. The most recent is 1997, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1984 | 1 |
| 1986 | 7 |
| 1987 | 2 |
| 1989 | 2 |
| 1990 | 1 |
| 1991 | 5 |
| 1992 | 1 |
| 1993 | 2 |
| 1996 | 1 |
| 1997 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K964571 | VISION CARDIOPLEGIA DELIVERY SYSTEM | DTR | Substantially Equivalent | |
| K962354 | DIOMED 15, 30, 60 SURGICAL DIODE LASER | GEX | Substantially Equivalent | |
| K920178 | CARDIOTOMY RESERVOIR W/20 MICRON FILITER | DTN | Substantially Equivalent | |
| K920618 | AUTOTRANSFUSION SUCTION SET | CAC | Substantially Equivalent | |
| K913181 | AUTOLOGOUS BLOOD PROCESSING SYSTEM | CAC | Substantially Equivalent | |
| K914396 | SURGI LIGHT NON-CONTACT FIBERS | GEX | Substantially Equivalent | |
| K912045 | TMP PRESSURE ISOLATORR, TMP PRESSURE MONITOR SYST | DXS | Substantially Equivalent | |
| K911523 | MODIFICATION TO MODEL 90-1460 LASER ADAPTER | GEX | Substantially Equivalent | |
| K910726 | LIGHT-TOUCH AND SURGI LIGHT FIBERS | GEX | Substantially Equivalent | |
| K904491 | TMP LEFT ATRIAL PRESSURE CATH CAT.# 100-00X-000 | DQO | Substantially Equivalent | |
| K903709 | SURGIMEDICS, SLP LAPAROSCOPIC CHOLANGIOGRAM CATH | GBZ | Substantially Equivalent | |
| K891909 | LIGHT-TOUCH/GS 905250 ND:YAG LASER MICRO PRO ENDOS | GEX | Substantially Equivalent | |
| K891130 | LIGHT-TOUCH LAPAROSCOPIC MODEL 905200 FIBEROPTIC | GEX | Substantially Equivalent | |
| K871068 | DISPOSABLE LASER PROTECTIVE DRAPE FOR CO2 LASER | KKX | Substantially Equivalent | |
| K870790 | REFLECTIVE MIRROR/CO2 LASER SURG CAT. #902002-000 | FTX | Substantially Equivalent | |
| K862815 | LASER SURGICAL ROD | GEX | Substantially Equivalent | |
| K863089 | DISPOSABLE LASER SPONGE SURGIMEDICS, 902001-000 | GDY | Substantially Equivalent | |
| K863241 | LASER ASSISTED SURGICAL LAPAROSCOPY KITS | Substantially Equivalent | ||
| K863293 | DISPOSABLE SUCTION CANNULA NO. 902008-000 | GEA | Substantially Equivalent | |
| K862213 | PRESSURE CONTROL VALVE & TUBING CAT. NO. 83-1010 | Substantially Equivalent | ||
| K862954 | LASER PLUME FILTERS | Substantially Equivalent | ||
| K862509 | CHARCOAL LASER SMOKE FILTER CATALOG NO. 901103-000 | JDY | Substantially Equivalent | |
| K843890 | CUSTOM INSTRUMENT DRAPE | HMW | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- CACApparatus, Autotransfusion
- GEACannula, Surgical, General & Plastic Surgery
- GBZCatheter, Cholangiography
- DQOCatheter, Intravascular, Diagnostic
- HMWDrape, Microscope, Ophthalmic
- KKXDrape, Surgical, Antimicrobial
- JDYEvacuator, Vapor, Cement Monomer
- DXSGauge, Pressure, Coronary, Cardiopulmonary Bypass
- GDYGauze/Sponge, Internal, X-Ray Detectable
- DTRHeat-Exchanger, Cardiopulmonary Bypass
- FTXMirror, General & Plastic Surgery
- GEXPowered Laser Surgical Instrument
- DTNReservoir, Blood, Cardiopulmonary Bypass
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