Company ยท US
Holter-Hausner Intl.
FDA 510(k) clearances and medical device recalls filed under this name, 1978 to 1988. Name variants (Inc, Corp, punctuation) are merged.
42510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JXG | Shunt, Central Nervous System And Components | 21 |
| HXA | Prosthesis, Tendon, Passive | 6 |
| GYK | Instrument, Shunt System Implantation | 5 |
| BZD | Ventilator, Non-Continuous (Respirator) | 1 |
| GXR | Cover, Burr Hole | 1 |
| HAO | Instrument, Surgical, Non-Powered | 1 |
| HXR | Spatula, Orthopedic | 1 |
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | 1 |
| KOB | Catheter, Suprapubic (And Accessories) | 1 |
| LFJ | Catheter, Subclavian | 1 |
| LKG | Port & Catheter, Implanted, Subcutaneous, Intraventricular | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 14, 1988 | K875287 | H-H FLUSHING RESERVOIR Holter-Hausner Intl. | JXG |
| Jan 19, 1988 | K874508 | H-H EXTERNAL VENTRICULAR DRAINAGE COLLECTION BAG Holter-Hausner Intl. | JXG |
| Sep 28, 1987 | K872293 | H-H HUNTER ACTIVE TENDON IMPLANT BC Holter-Hausner Intl. | HXA |
| Sep 28, 1987 | K872285 | H-H HUNTER ACTIVE TENDON IMPLANT DC Holter-Hausner Intl. | HXA |
| Sep 28, 1987 | K872284 | H-H HUNTER ACTIVE TENDON IMPLANT PC Holter-Hausner Intl. | HXA |
| May 14, 1987 | K871351 | H-H HARRIS NEONATAL NASAL CANNULA SET FOR CPAP Holter-Hausner Intl. | BZD |
| May 1, 1987 | K870660 | H-H EXTERNAL VENTRICULAR DRAIN (EVD) COMP./SYSTEMS Holter-Hausner Intl. | JXG |
| Jan 13, 1987 | K865075 | H-H SUBGALEAL TROCAR Holter-Hausner Intl. | GYK |
| Oct 16, 1985 | K853437 | H-H HUNTER TENDON ROD Holter-Hausner Intl. | |
| Oct 16, 1985 | K853436 | H-H HUNTER PASSIVE TENDON IMPLANT Holter-Hausner Intl. | HXR |
| Sep 30, 1985 | K853438 | H-H HUNTER ACTIVE TENDON IMPLANT Holter-Hausner Intl. | HXA |
| Sep 18, 1985 | K853371 | H-H ATRIAL CATHETERS & PERITONEAL CATHETERS Holter-Hausner Intl. | JXG |
| Sep 18, 1985 | K853370 | H-H CATHETER PASSERS(TACL DESIGN Holter-Hausner Intl. | GYK |
| Sep 11, 1985 | K853369 | H-H FIXATION & JOINING CONNECTORS Holter-Hausner Intl. | JXG |
| Sep 11, 1985 | K853367 | H-H BURR HOLE CATHETER SUPPORT Holter-Hausner Intl. | GXR |
| Sep 11, 1985 | K853366 | H-H UNITIZED STANDARD SHUNT/RESERVOIR SHUNT Holter-Hausner Intl. | JXG |
| Sep 6, 1985 | K853368 | H-H SHUNT INTRODUCER Holter-Hausner Intl. | GYK |
| Sep 5, 1985 | K853365 | H-H FIFTH VENTRICLE Holter-Hausner Intl. | JXG |
| Sep 5, 1985 | K853364 | H-H RICKHAM TYPE RESERVOIR Holter-Hausner Intl. | JXG |
| Sep 3, 1985 | K853363 | H-H CRUCIFORM-SLIT VALVE Holter-Hausner Intl. | JXG |
| Sep 3, 1985 | K853362 | H-H SLOTTED VENTRICULAR CATHETER/SLOTTED CATHETER Holter-Hausner Intl. | JXG |
| Aug 28, 1985 | K853361 | H-H VENTRICULAR CATHETERS & RESERVOIRS Holter-Hausner Intl. | JXG |
| Aug 27, 1985 | K853458 | H-H SEXTON SCUP URINE MGMT. SYS Holter-Hausner Intl. | KNX |
| Apr 17, 1985 | K843013 | H-H TENDEON IMPLANT Holter-Hausner Intl. | |
| Oct 4, 1984 | K843158 | SEXTON CYSTOTOMY URINE PUMP Holter-Hausner Intl. | KOB |
| May 14, 1984 | K841553 | H-H SHUNT PASSERS Holter-Hausner Intl. | GYK |
| Mar 6, 1984 | K833672 | HH SUBCUTANEOUS ACCESS PORT Holter-Hausner Intl. | LKG |
| Apr 8, 1983 | K830894 | H-H IN-LINE VALVED CATHETER 2 TYPES Holter-Hausner Intl. | JXG |
| Jul 22, 1982 | K822048 | H-H NERVE ROOT RETRACTOR Holter-Hausner Intl. | HAO |
| May 28, 1982 | K821012 | H-H ALIMENTATION CATHETERS Holter-Hausner Intl. | LFJ |
| Mar 1, 1982 | K820312 | H-H RICKHAM TYPE RESERVOIR Holter-Hausner Intl. | JXG |
| Feb 24, 1982 | K820311 | H-H BURR HOLE CATHETER SUPPORT Holter-Hausner Intl. | JXG |
| Jan 31, 1980 | K800168 | H-H FIFTH VENTRICLE Holter-Hausner Intl. | JXG |
| Dec 31, 1979 | K792639 | H-H SHUNT INTRODUCER Holter-Hausner Intl. | GYK |
| Aug 3, 1979 | K791076 | H-H SLOTTED VENTRICULAR CATHETER Holter-Hausner Intl. | JXG |
| Aug 3, 1979 | K791075 | H-H SLOTTED CATHETER-RESERVOIR Holter-Hausner Intl. | JXG |
| May 11, 1979 | K790849 | H-H FIXATION AND JOINING CONNECTORS Holter-Hausner Intl. | JXG |
| Jan 26, 1979 | K790126 | VALVE, H-H CRUCIFORM SLIT Holter-Hausner Intl. | JXG |
| Jan 15, 1979 | K782105 | CATHETERS, H-H VENTRICULAR Holter-Hausner Intl. | JXG |
| Dec 4, 1978 | K781943 | TENDON ROD MODEL OR41PO3-6 Holter-Hausner Intl. | HXA |
| Nov 14, 1978 | K781768 | CATHETERS, H-H ATRIAL AND PERITONEAL Holter-Hausner Intl. | JXG |
| Mar 17, 1978 | K780320 | PASSIVE TENDON IMPLANT Holter-Hausner Intl. | HXA |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||