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510(k) K853368

H-H SHUNT INTRODUCER by Holter-Hausner Intl. — Product Code GYK

K853368 is an FDA 510(k) premarket notification submitted by Holter-Hausner Intl. for the device "H-H SHUNT INTRODUCER". The FDA issued a decision of Substantially Equivalent on Sep 6, 1985. The device falls under product code GYK (Instrument, Shunt System Implantation), a Class I device regulated under 21 CFR 882.4545. Holter-Hausner Intl. has 41 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Sep 6, 1985
Date Received
Aug 12, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Instrument, Shunt System Implantation
Device Class
Class I
Regulation Number
882.4545
Review Panel
NE
Submission Type
510(k) Exempt

Other clearances by Holter-Hausner Intl.

  • K875287 — H-H FLUSHING RESERVOIR (Jul 14, 1988)
  • K874508 — H-H EXTERNAL VENTRICULAR DRAINAGE COLLECTION BAG (Jan 19, 1988)
  • K872293 — H-H HUNTER ACTIVE TENDON IMPLANT BC (Sep 28, 1987)
  • K872284 — H-H HUNTER ACTIVE TENDON IMPLANT PC (Sep 28, 1987)
  • K872285 — H-H HUNTER ACTIVE TENDON IMPLANT DC (Sep 28, 1987)
  • K871351 — H-H HARRIS NEONATAL NASAL CANNULA SET FOR CPAP (May 14, 1987)
  • K870660 — H-H EXTERNAL VENTRICULAR DRAIN (EVD) COMP./SYSTEMS (May 1, 1987)
  • K865075 — H-H SUBGALEAL TROCAR (Jan 13, 1987)
  • K853437 — H-H HUNTER TENDON ROD (Oct 16, 1985)
  • K853436 — H-H HUNTER PASSIVE TENDON IMPLANT (Oct 16, 1985)

Other clearances for product code GYK

  • K962761 — REIGEL TUNNELING DEVICE (Oct 11, 1996)
  • K934391 — V/P AND L/P CATHETER PASSERS (Nov 19, 1993)
  • K930606 — PS MEDICAL DISPOSABLE SUBCUTANEOUS CATH PASSER (Sep 10, 1993)
  • K932273 — CORDIS TUNNELER (Aug 23, 1993)
  • K895868 — HEYER-SCHULTE DISPOSABLE PERITONEAL CATHETER PASSE (Oct 31, 1989)
  • K883607 — PEEL-AWAY INTRODUCER FOR VENTRICULAR CATHETER (Sep 30, 1988)
  • K873771 — HEYER-SCHULTE(R) ONE PIECE SHUNT VENT. CATH. INTRO (Dec 18, 1987)
  • K865075 — H-H SUBGALEAL TROCAR (Jan 13, 1987)
  • K853370 — H-H CATHETER PASSERS(TACL DESIGN (Sep 18, 1985)
  • K841553 — H-H SHUNT PASSERS (May 14, 1984)

FDA data resources

Source: FDA 510(k) database entry for K853368. Report a data issue: hello@regdatalab.com.