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510(k) K852277

CATAPRESS TOURNIGUET by Boehringer Ingelheim Pharmaceuticals, Inc. — Product Code GAX

K852277 is an FDA 510(k) premarket notification submitted by Boehringer Ingelheim Pharmaceuticals, Inc. for the device "CATAPRESS TOURNIGUET". The FDA issued a decision of Substantially Equivalent on June 27, 1985. The device falls under product code GAX (Tourniquet, Nonpneumatic), a Class I device regulated under 21 CFR 878.5900. Boehringer Ingelheim Pharmaceuticals, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 1985
Date Received
May 29, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tourniquet, Nonpneumatic
Device Class
Class I
Regulation Number
878.5900
Review Panel
SU
Submission Type

Other clearances by Boehringer Ingelheim Pharmaceuticals, Inc.

  • K863049 — INHALATION AID (October 15, 1986)

Other clearances for product code GAX

  • K931198 — UNIQUET (September 1, 1993)
  • K881398 — TOURNIQUET (April 29, 1988)
  • K881176 — STERILE ESMARCH BANDAGE (April 11, 1988)
  • K875092 — DEGANIA SILICONE TOURNIQUET (January 7, 1988)
  • K873928 — UNIVERSAL TOURNIQUET (October 23, 1987)
  • K872003 — KINDERWRAP (June 23, 1987)
  • K864897 — DALE VENIPUNCTURE TOURNIQUET, PRODUCT NO. 1335 (January 12, 1987)
  • K853472 — FINGER TOURNIQUETTE (October 10, 1985)
  • K853537 — VELCRO TOURNIQUET (September 12, 1985)
  • K851482 — TOURNIQUET (April 29, 1985)

FDA data resources