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510(k) K872230

MODEL 366-29 ADAPTAID(TM) ADAPTER SLEEVE by Intermedics, Inc. — Product Code DBT

K872230 is an FDA 510(k) premarket notification submitted by Intermedics, Inc. for the device "MODEL 366-29 ADAPTAID(TM) ADAPTER SLEEVE". The FDA issued a decision of Substantially Equivalent on September 15, 1987. The device falls under product code DBT (Factor Xiii A, S, Antigen, Antiserum, Control), a Class I device regulated under 21 CFR 866.5330. Intermedics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 1987
Date Received
June 9, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Factor Xiii A, S, Antigen, Antiserum, Control
Device Class
Class I
Regulation Number
866.5330
Review Panel
HE
Submission Type

Other clearances by Intermedics, Inc.

  • K954610 — MODEL 430-07 ENDOCARDIAL PACING LEAD (December 16, 1996)
  • K955122 — INTERMEDICS MODEL 436-07 BIPOLAR & MODEL 437-07 UNIPOLAR IMPLANTABLE ENDOCARDIAL (November 4, 1996)
  • K962174 — BIPLR IM EN PAC LEADS (430-07,432-03,436-02 & 07, 438-05 & 07) (August 21, 1996)
  • K955550 — CARDIFIX EZ BIPOLAR/UNIPOLAR ENDOCARDIAL PACING LEAD (June 19, 1996)
  • K960281 — IMPLANTABLE PACING LEADS/IMPLANTABLE ACCESSORY/NON-IMPLANTABLE ACCESSORY (June 18, 1996)
  • K954719 — INTERMEDICS MODEL 430-07 BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD (February 27, 1996)
  • K933278 — INTERMEDICS TRIANGLE CHEST PROBE MODEL 526-04 (March 15, 1995)
  • K922042 — CARDIFIX ENDOCARDIAL PACING LEAD (April 29, 1993)
  • K922972 — MODELS 438-05 AND 435-05 IMPLANTABLE PACING LEAD (January 22, 1993)
  • K920530 — INTERMEDICS MODEL 366-15 VS 1 HEADER PLUG (March 17, 1992)

FDA data resources