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510(k) K960209

CPR HEART PACK by Custom Pack Reliability — Product Code GAW

K960209 is an FDA 510(k) premarket notification submitted by Custom Pack Reliability for the device "CPR HEART PACK". The FDA issued a decision of Substantially Equivalent on April 4, 1996. The device falls under product code GAW (Suture, Nonabsorbable, Synthetic, Polypropylene), a Class II device regulated under 21 CFR 878.5010. Custom Pack Reliability has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 1996
Date Received
January 16, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Synthetic, Polypropylene
Device Class
Class II
Regulation Number
878.5010
Review Panel
SU
Submission Type

Other clearances by Custom Pack Reliability

  • K960205 — CPR TRACHEOTOMY CARE TRAY (August 27, 1996)
  • K960243 — CPR C-SECTION DELIVERY PACK (May 23, 1996)
  • K960239 — CPR D & C TRAY (May 23, 1996)
  • K960216 — CPR SUCTION CATHETER KIT (April 15, 1996)
  • K960210 — CPR ORTHO HAND PACK (April 12, 1996)
  • K960211 — CPR TOTAL KNEE PACK (April 12, 1996)
  • K960206 — CPR DRESSING CHANGE TRAY (April 12, 1996)
  • K960213 — CPR TOTAL HIP PACK (April 12, 1996)
  • K960215 — CPR URETHRAL CATHETER TRAY (April 1, 1996)
  • K960214 — CPR FOLEY CAHTETER KIT (April 1, 1996)

Other clearances for product code GAW

  • K253572 — STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATA (March 27, 2026)
  • K233355 — Cypris eXact Suturing System (January 12, 2024)
  • K230746 — Non absorbable Surgical Polypropylene Suture (September 14, 2023)
  • K221280 — Vesseal (December 9, 2022)
  • K211178 — DURAMESH Mesh Suture (September 2, 2022)
  • K192953 — APTOS Threads – Polypropylene Surgical Sutures (August 27, 2020)
  • K193530 — Deklene MAXX (March 19, 2020)
  • K191299 — Silhouette Featherlift / Silhouette Lift (June 14, 2019)
  • K173747 — REXLENE (December 21, 2018)
  • K180321 — Aesculap Optilene Nonabsorbable Suture (March 7, 2018)

FDA data resources