ATTACHABLE LANZ (TENTATIVE)— 510(k) K885216

Substantially Equivalent

Mallinckroot, Inc.

FDA 510(k) clearance K885216 for ATTACHABLE LANZ (TENTATIVE), Substantially Equivalent on 1989-03-14. Applicant: Mallinckroot, Inc.. Device class: 2.

Clearance details

Applicant: Mallinckroot, Inc.
Product code: Code BSK
Device class: Class 2
Regulation: 21 CFR 868.5750
Advisory panel: Anesthesiology
Date received: 1988-12-19
Decision date: 1989-03-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Argyle, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BSK

K261499 — TrachFlush2026-08-13
K243562 — CuffGuard2025-08-12
K242642 — CuffTrek2025-03-07
K220854 — TrachCuff Cuff Controller2023-04-14
K221477 — AG100s2022-12-29

More clearances from Mallinckroot, Inc.

K983830 — COPPERHEAD 5 FR. PTA CATHETER, FINCH 4 FR. PTA CATHETER1999-04-16
K894445 — MODIFIED SOFTOUCH INTRODUCER W/HEMO VALVE & SIDE1989-10-02
K885348 — A-V(TM) SOFTOUCH UHF CARDIAC PIGTAIL1989-05-15
K884159 — SOFTOUCH INTRODUCER W/HEMOSTASIS VALVE & SIDEPORT1989-02-22
K884481 — CLEAR SHOT ANGIOPLASTY BALLOON INFLATION DEVICE1989-01-10

Data sourced from openFDA. This site is unofficial and independent of the FDA.